Vaginal AtrophyPhase 2/3NCT05627791
Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman
A Phase 2/3 study testing Oxytocin in people with Vaginal Atrophy and Oxytocin Gel, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy, Oxytocin Gel, Postmenopausal Women
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteThailand
- Study dates
- 30 Nov 2022to 28 Aug 2023
- Phase
- Phase 2/3
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language.
Who cannot join
- Have acute vulvovaginitis (vaginal swab for wet smear and KOH)
- Patients who have used hormonal replacement therapy within 12 months
- Patients with a history of smoking
- Patients who have used vaginal lubricant or moisturizer
- Patients with an allergic history of oxytocin or gel components
- Morbid obesity BMI > 30 kg/m2
- Patients who have used vitamin E supplement
- Patients who unable to perform per vaginal examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman: A Randomized Placebo-controlled Trial
Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.
Read the detailed description
Random and conducted on 56 postmenopausal women who meet the inclusion criteria and excluded participants that have exclusion criteria. All women provided written informed consent before data collection.
- st Visit: The vagina was assessed regarding infection and any abnormal discharge. The participants were evaluated vaginal signs of vaginal atrophy by per vaginal examination and assessed vaginal health index score. The subjective symptoms were assessed by The most bothersome score. The vaginal pH was tested with a Nitrazine paper. The vaginal swab was done and the specimen was sent for a cytological test - vaginal maturation index evaluation (VMI). The participants were separated into two groups 1. Oxytocin gel group and 2. Placebo gel group then applied gel 1 ml. (400IU of oxytocin in oxytocin gel) per day for 8 weeks consecutively. The subjective symptoms were assessed at 2 and 4 weeks by phone.
- nd Visit: The participants were assessed the same as 1st visit that recorded vaginal health index score, subjective symptoms, vaginal pH, and vaginal maturation index evaluation.
- Being tested
- Oxytocin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Oxytocin vaginal gel
Oxytocin vaginal gel that have oxytocin 400IU/1ml of gel, base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0
PlaceboDrug
Placebo gel that have base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 without oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin gel | Experimental | Oxytocin gel 400IU per 1 ml (on HPMC 4,000 cps base gel), applied at vaginal canal 1 ml per day for 8 weeks Receives: Drug: Oxytocin |
| Placebo gel | Placebo comparator | Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of vaginal cytology test for vaginal maturation index measurement
VMI = 0.2 × % parabasal cells+0.6 × % intermediate cells+1.0 × % superficial cells score below 52 mean significant vulvovaginal atrophy
Measured: Change from baseline VMI at 8 weeks
Secondary outcomes (6)
Comparison of vaginal health index; scoring from vaginal examination
Score 5-25, below 15 mean significant vulvovaginal atrophy from physical examination
Measured: Change from baseline vaginal health index score at 8 weeks
Comparison of subjective symptoms by The most bothersome symptoms score
score from 0-4, 0 = absent, 4 = severe symptom
Measured: Change from baseline subjective symptom score at 2 weeks
Comparison of subjective symptoms by The most bothersome symptoms score
score from 0-4, 0 = absent, 4 = severe symptom
Measured: Change from baseline subjective symptom score at 4 weeks
Comparison of subjective symptoms by The most bothersome symptoms score
score from 0-4, 0 = absent, 4 = severe symptom
Measured: Change from baseline subjective symptom score at 8 weeks
Comparison of vaginal pH between two group
pH from Nitrazine paper test
Measured: Vaginal pH at 8 weeks
Comparison of adverse events between two group
present of adverse events
Measured: adverse events within 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start30 Nov 2022
- Primary completion31 Jul 2023
- Study completion28 Aug 2023
Why it stopped: Unable to recuit participant number in time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627791
- Sponsor's protocol ID
- 65065
- Status last verified
- Aug 2023
- First submitted
- 9 Nov 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zohrabi I, Abedi P, Ansari S, Maraghi E, Shakiba Maram N, Houshmand G. The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial. BMC Womens Health. 2020 May 19;20(1):108. doi: 10.1186/s12905-020-00935-5.
PubMed 32429977Alvisi S, Gava G, Orsili I, Giacomelli G, Baldassarre M, Seracchioli R, Meriggiola MC. Vaginal Health in Menopausal Women. Medicina (Kaunas). 2019 Sep 20;55(10):615. doi: 10.3390/medicina55100615.
PubMed 31547180Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
PubMed 27472999Jonasson AF, Edwall L, Uvnas-Moberg K. Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study. Menopause Int. 2011 Dec;17(4):120-5. doi: 10.1258/mi.2011.011030. Epub 2011 Nov 25.
PubMed 22120944Fianu Jonasson A, Bixo M, Sundstrom Poromaa I, Astrom M. Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital(R) Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study. Med Devices (Auckl). 2020 Oct 5;13:339-347. doi: 10.2147/MDER.S265824. eCollection 2020.
PubMed 33116956Kallak TK, Uvnas-Moberg K. Oxytocin stimulates cell proliferation in vaginal cell line Vk2E6E7. Post Reprod Health. 2017 Mar;23(1):6-12. doi: 10.1177/2053369117693148. Epub 2017 Mar 8.
PubMed 28381099Hess R, Austin RM, Dillon S, Chang CC, Ness RB. Vaginal maturation index self-sample collection in mid-life women: acceptability and correlation with physician-collected samples. Menopause. 2008 Jul-Aug;15(4 Pt 1):726-9. doi: 10.1097/gme.0b013e31816c5541.
PubMed 18427354Torky HA, Taha A, Marie H, El-Desouky E, Raslan O, Moussa AA, Ahmad AM, Abo-Louz A, Zaki S, Fares T, Eesa A. Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: a randomized, controlled trial. Climacteric. 2018 Apr;21(2):174-178. doi: 10.1080/13697137.2017.1421924. Epub 2018 Jan 19.
PubMed 29347848Al-Saqi SH, Uvnas-Moberg K, Jonasson AF. Intravaginally applied oxytocin improves post-menopausal vaginal atrophy. Post Reprod Health. 2015 Sep;21(3):88-97. doi: 10.1177/2053369115577328. Epub 2015 May 19.
PubMed 25995333
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05627791
- Acronym / sponsor ID
- 65065
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recuit participant number in time.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 28 Nov 2022 (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.
Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.
Detailed description
Random and conducted on 56 postmenopausal women who meet the inclusion criteria and excluded participants that have exclusion criteria. All women provided written informed consent before data collection.
- st Visit: The vagina was assessed regarding infection and any abnormal discharge. The participants were evaluated vaginal signs of vaginal atrophy by per vaginal examination and assessed vaginal health index score. The subjective symptoms were assessed by The most bothersome score. The vaginal pH was tested with a Nitrazine paper. The vaginal swab was done and the specimen was sent for a cytological test - vaginal maturation index evaluation (VMI). The participants were separated into two groups 1. Oxytocin gel group and 2. Placebo gel group then applied gel 1 ml. (400IU of oxytocin in oxytocin gel) per day for 8 weeks consecutively. The subjective symptoms were assessed at 2 and 4 weeks by phone.
- nd Visit: The participants were assessed the same as 1st visit that recorded vaginal health index score, subjective symptoms, vaginal pH, and vaginal maturation index evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin gel | Experimental | Drug: OxytocinOxytocin gel 400IU per 1 ml (on HPMC 4,000 cps base gel), applied at vaginal canal 1 ml per day for 8 weeks |
| Placebo gel | Placebo comparator | Drug: PlaceboPlacebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language.
Key exclusion criteria (8 listed)
- Have acute vulvovaginitis (vaginal swab for wet smear and KOH)
- Patients who have used hormonal replacement therapy within 12 months
- Patients with a history of smoking
- Patients who have used vaginal lubricant or moisturizer
- Patients with an allergic history of oxytocin or gel components
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 |
|---|---|---|
| OxytocinAlso: Oxytocin vaginal gelOxytocin vaginal gel that have oxytocin 400IU/1ml of gel, base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 | Drug | Oxytocin gel |
| PlaceboPlacebo gel that have base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 without oxytocin | Drug | Placebo gel |
Primary outcome
Comparison of vaginal cytology test for vaginal maturation index measurement
Time frame: Change from baseline VMI at 8 weeks
VMI = 0.2 × % parabasal cells+0.6 × % intermediate cells+1.0 × % superficial cells score below 52 mean significant vulvovaginal atrophy
6 secondary outcomes
Comparison of vaginal health index; scoring from vaginal examination
Time frame: Change from baseline vaginal health index score at 8 weeks
Comparison of subjective symptoms by The most bothersome symptoms score
Time frame: Change from baseline subjective symptom score at 2 weeks
Comparison of subjective symptoms by The most bothersome symptoms score
Time frame: Change from baseline subjective symptom score at 4 weeks
Comparison of subjective symptoms by The most bothersome symptoms score
Time frame: Change from baseline subjective symptom score at 8 weeks
Comparison of vaginal pH between two group
Time frame: Vaginal pH at 8 weeks
Comparison of adverse events between two group
Time frame: adverse events within 8 weeks
Results and safety
The study was stopped early (reason given: Unable to recuit participant number in time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 32429977Zohrabi I, Abedi P, Ansari S, Maraghi E, Shakiba Maram N, Houshmand G. The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial. BMC Womens Health. 2020 May 19;20(1):108. doi: 10.1186/s12905-020-00935-5.
- Background: PubMed 31547180Alvisi S, Gava G, Orsili I, Giacomelli G, Baldassarre M, Seracchioli R, Meriggiola MC. Vaginal Health in Menopausal Women. Medicina (Kaunas). 2019 Sep 20;55(10):615. doi: 10.3390/medicina55100615.
- Background: PubMed 27472999Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
- Background: PubMed 22120944Jonasson AF, Edwall L, Uvnas-Moberg K. Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study. Menopause Int. 2011 Dec;17(4):120-5. doi: 10.1258/mi.2011.011030. Epub 2011 Nov 25.
- Background: PubMed 33116956Fianu Jonasson A, Bixo M, Sundstrom Poromaa I, Astrom M. Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital(R) Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study. Med Devices (Auckl). 2020 Oct 5;13:339-347. doi: 10.2147/MDER.S265824. eCollection 2020.
- Background: PubMed 28381099Kallak TK, Uvnas-Moberg K. Oxytocin stimulates cell proliferation in vaginal cell line Vk2E6E7. Post Reprod Health. 2017 Mar;23(1):6-12. doi: 10.1177/2053369117693148. Epub 2017 Mar 8.
- Background: PubMed 18427354Hess R, Austin RM, Dillon S, Chang CC, Ness RB. Vaginal maturation index self-sample collection in mid-life women: acceptability and correlation with physician-collected samples. Menopause. 2008 Jul-Aug;15(4 Pt 1):726-9. doi: 10.1097/gme.0b013e31816c5541.
- Background: PubMed 29347848Torky HA, Taha A, Marie H, El-Desouky E, Raslan O, Moussa AA, Ahmad AM, Abo-Louz A, Zaki S, Fares T, Eesa A. Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: a randomized, controlled trial. Climacteric. 2018 Apr;21(2):174-178. doi: 10.1080/13697137.2017.1421924. Epub 2018 Jan 19.
- Background: PubMed 25995333Al-Saqi SH, Uvnas-Moberg K, Jonasson AF. Intravaginally applied oxytocin improves post-menopausal vaginal atrophy. Post Reprod Health. 2015 Sep;21(3):88-97. doi: 10.1177/2053369115577328. Epub 2015 May 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxytocin in people with Vaginal Atrophy and Oxytocin Gel, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recuit participant number in time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of vaginal cytology test for vaginal maturation index measurement (time frame: Change from baseline VMI at 8 weeks). 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 NCT05627791, which also lists 9 linked publications.
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 31 Aug 2023.