Senile VaginitisPhase 1NCT03898401
Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
A Phase 1 study testing Platelet rich plasma in people with Senile Vaginitis, run by Ain Shams University at 2 sites in Egypt.
Trial summary
30 postmenopausal females with senile vaginitis will be enrolled with score of <15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Senile Vaginitis
- What is being tested?
- Platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Mar 2019to 30 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal for at least 3 years.
- Vaginal health index <15.
- Any parity.
Who cannot join
- Women with vaginal infection.
- Women taking estrogen therapy for senile vaginitis.
- Any patient with medical disorder especially diabetes mellitus.
- Previous vaginal surgery as fistula repair or classical repair.
- Vaginal prolapse
- Any patient taking chemo or radiotherapy.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ain shams University
Cairo, Elabbasia, 13211
Rasha Abdulhady, 01224448449, rashamedhat30@gmail.com
Rasha Abdulhady
- Recruiting
Ain shams university hospital
Cairo
Rasha M Abdul-hady, Lecturer, +20122 444 8449, Rashamedhat30@gmail.com
About this study
30 postmenopausal females with senile vaginitis will be enrolled with score of <15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.
Read the detailed description
30 postmenopausal females with senile vaginitis will be enrolled with score of <15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.
The patients will be seen in Ain shams university gynecological clinic and will not be paid either to receive the procedure or to complete the survey. All patients were fully informed of the innovative therapeutic and experimental nature of the localized PRP injection and consented to the procedure.
The materials and equipment included the following:
- 5 cc syringes.
- 27 gauge needles.
- Centrifuge with proprietary collection system.
- Calcium chloride 10% (for activation of PRP).
- and a topical anesthetic cream compounded with a base that prevents irritation and promotes absorption through the vaginal mucosa. Active ingredients will be as follows: bupivicaine, lidocaine, and tetracaine with percent concentrations of 20/8/8 respectively.
First, a topical anesthetic cream will be applied to the posterior vaginal wall. Delaying the PRP injection for 20 minutes after anesthetic application achieved complete or near complete analgesia for the procedure. Peripheral blood will be drawn from the arm and centrifuged to yield 5 cc of PRP. The Regen® system concentrates 5ml of PRP from 10 ml of whole blood using a gel separator.
Study Interventions:
After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.
- Conditions
- Senile Vaginitis
- Being tested
- Platelet rich plasma
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaCombination product
After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 2 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 3 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 4 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 5 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 6 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 7 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 8 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 9 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 10 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 11 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 12 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 13 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 14 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 15 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 16 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 17 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 18 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 19 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 20 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 21 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 22 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 23 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 24 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 25 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 26 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 27PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 28 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 29 PRP | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
| 30 PRp | Experimental | Inclusion criteria:
I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity.
Exclusion criteria:
I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. Receives: Combination Product: Platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of vaginal mucosa using vaginal health index score
Elasticity,fluid volume,integrity,pH,moisture
Measured: 6 months
Secondary outcomes (1)
Female Sexual Distress (FSD) scale
How often did you feel distreesed about your sexual life ?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
18 Mar 201930 Oct 2019
- First posted2 Apr 2019
- Study start18 Mar 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Senile VaginitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Responsible party
- Principal investigator, rasha medhat abdul-hady, Ain Shams University
- Investigators
- Rasha Medhat, Professor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898401
- Sponsor's protocol ID
- 2455
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamid ASA, AbdAllah AM, Fathi HM, Eldin AMB, Abd El Hadi RMM. Value of injection of plasma-rich platelets in the vaginal mucosa in cases with vulvovaginal atrophy: a prospective double-blinded randomized controlled study. BMC Womens Health. 2025 Nov 25;25(1):576. doi: 10.1186/s12905-025-04076-5.
PubMed 41291715
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis
- ClinicalTrials.gov ID
- NCT03898401
- Acronym / sponsor ID
- 2455
- Conditions
- Senile Vaginitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
30 postmenopausal females with senile vaginitis will be enrolled with score of <15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.
Detailed description
30 postmenopausal females with senile vaginitis will be enrolled with score of <15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.
The patients will be seen in Ain shams university gynecological clinic and will not be paid either to receive the procedure or to complete the survey. All patients were fully informed of the innovative therapeutic and experimental nature of the localized PRP injection and consented to the procedure.
The materials and equipment included the following:
- 5 cc syringes.
- 27 gauge needles.
- Centrifuge with proprietary collection system.
- Calcium chloride 10% (for activation of PRP).
- and a topical anesthetic cream compounded with a base that prevents irritation and promotes absorption through the vaginal mucosa. Active ingredients will be as follows: bupivicaine, lidocaine, and tetracaine with percent concentrations of 20/8/8 respectively.
First, a topical anesthetic cream will be applied to the posterior vaginal wall. Delaying the PRP injection for 20 minutes after anesthetic application achieved complete or near complete analgesia for the procedure. Peripheral blood will be drawn from the arm and centrifuged to yield 5 cc of PRP. The Regen® system concentrates 5ml of PRP from 10 ml of whole blood using a gel separator.
Study Interventions:
After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 30
| Arm | Type | Receives |
|---|---|---|
| 1 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 2 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 3 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 4 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 5 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 6 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 7 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 8 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 9 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 10 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 11 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 12 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 13 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 14 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 15 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 16 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 17 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 18 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 19 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 20 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 21 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 22 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 23 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 24 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 25 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 26 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 27PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 28 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 29 PRP | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
| 30 PRp | Experimental | Combination Product: Platelet rich plasmaInclusion criteria: I. Postmenopausal for at least 3 years. II. Vaginal health index <15. III. Any parity. Exclusion criteria: I. Women with vaginal infection. II. Women taking estrogen therapy for senile vaginitis. III. Any patient with medical disorder especially diabetes mellitus. IV. Previous vaginal surgery as fistula repair or classical repair. V. Vaginal prolapse VI. Any patient taking chemo or radiotherapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal for at least 3 years.
- Vaginal health index <15.
- Any parity.
Key exclusion criteria (6 listed)
- Women with vaginal infection.
- Women taking estrogen therapy for senile vaginitis.
- Any patient with medical disorder especially diabetes mellitus.
- Previous vaginal surgery as fistula repair or classical repair.
- Vaginal prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasmaAfter isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months. | Combination product | 1 PRP, 10 PRP, 11 PRP, 12 PRP, 13 PRP, 14 PRP, 15 PRP, 16 PRP, 17 PRP, 18 PRP, 19 PRP, 2 PRP, 20 PRP, 21 PRP, 22 PRP, 23 PRP, 24 PRP, 25 PRP, 26 PRP, 27PRP, 28 PRP, 29 PRP, 3 PRP, 30 PRp, 4 PRP, 5 PRP, 6 PRP, 7 PRP, 8 PRP, 9 PRP |
Primary outcome
Evaluation of vaginal mucosa using vaginal health index score
Time frame: 6 months
Elasticity,fluid volume,integrity,pH,moisture
1 secondary outcome
Female Sexual Distress (FSD) scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 41291715Hamid ASA, AbdAllah AM, Fathi HM, Eldin AMB, Abd El Hadi RMM. Value of injection of plasma-rich platelets in the vaginal mucosa in cases with vulvovaginal atrophy: a prospective double-blinded randomized controlled study. BMC Womens Health. 2025 Nov 25;25(1):576. doi: 10.1186/s12905-025-04076-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasha Medhat, Professor principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet rich plasma in people with Senile Vaginitis, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasha Medhat, Professor (01224448449, rashamedhat30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of vaginal mucosa using vaginal health index score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.