Vaginal AtrophyNCT03998722
Evaluation of VagiVital® for Treatment of Vaginal Atrophy
A study testing Vagivital in people with Vaginal Atrophy, run by PepTonic Medical AB at 1 site in Sweden.
Trial summary
An open study to evaluate the ability of VagiVital in reducing the severity of moderate to severe symptoms of vaginal atrophy for women under treatment on adjuvant aromatase inhibitor therapy. Vaginal pH and a self-assessment of the symptoms will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Vagivital
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jun 2019to 24 Jun 2020
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in the investigation, a subject must:
- Be a female, 18 years or older, who is willing to participate in the study as indicated by signing the informed consent.
- Women over the age of 18 who have been diagnosed with cancer and are currently taking adjuvant AI therapy who also complain of vaginal atrophy symptoms including vaginal dryness, vaginal itching, frequent urinary tract infections, or dyspareunia are candidates for this study. They also have to be sexually active or wanted to be so, but couldn´t because of problems with vaginal atrophy.
- Have one moderate to severe VA symptom (vaginal irritation and itching, vaginal dryness, dysuria, dyspareunia or presence of vaginal bleeding associated with sexual activity) that has been identified by the subject as being the most bothersome to her according to the scale presented in APPENDIX B.
- Be judged by the Principal Investigator as being in otherwise good health based on the medical evaluation performed at baseline. The medical evaluation findings must include:
- A normal or clinically non-significant finding at physical examination, including vital signs (blood pressure and heart rate).
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- A normal or clinically non-significant finding at gynecological examination.
- A normal or clinically non-significant finding at clinical breast examination. An acceptable breast examination is defined as an examination in which no masses or other findings are identified which are suspected of being malignant.
- Urine analysis test results within reference limits or with non-significant deviations from reference values.
- A sitting systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg at screening. Hypertensive subjects controlled with stable medications, who have a blood pressure ≤ 150 (systolic) and ≤ 90 (diastolic) mmHg are suitable for inclusion
- Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and at Visits 2 and 3.
Who cannot join
- To participate in the investigation, a subject must not:
- Be currently hospitalized.
- Have a history of ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
- Have a history of undiagnosed vaginal bleeding.
- Have an ongoing urogenital infection at the screening visit.
- Any contraindication to the gel (VagiVital) therapy and allergy to the use of any components of the investigational device.
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- Have a history of drug and/or alcohol abuse within one year of start of study.
- Have used any prescription or OTC medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to screening procedures.
- Have used any type of vaginal lubricants and moisturizers within 24 hours prior to screening procedures.
- Have used estrogen alone or estrogen/progestin for any of the following time periods:
- Vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to Screening procedures;
- Transdermal estrogen alone or estrogen/progestin products including percutaneous estrogen gels for at least 12 weeks prior to screening procedures.
- Oral estrogen and/or progestin therapy within 12 weeks prior to Screening procedures;
- Intrauterine progestin therapy within 12 weeks prior to Screening procedures;
- Progestin implants and estrogen alone injectable drug therapy within 12 weeks prior to screening procedures;
- Estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to screening procedures;
- Have any reason, which in the opinion of the Principal Investigator would prevent the subject from safely participating in the study or complying with protocol requirements.
- Have participated in another clinical trial within 90 days prior to screening, have received an investigational drug within the three months prior to the initial dose of study medication, or be likely to participate in another clinical trial or receive another investigational medication during the study.
- Have contraindication to any planned study procedure.
- Fulfils any other reason for exclusion as stated by the Declaration of Helsinki.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Single-arm Investigation to Evaluate the Use of VagiVital® for Treatment of Vaginal Atrophy in Cancer Patients Undergoing Adjuvant Aromatase Inhibitor Therapy - 12 Weeks Follow-up
An open study to evaluate the ability of VagiVital in reducing the severity of moderate to severe symptoms of vaginal atrophy for women under treatment on adjuvant aromatase inhibitor therapy. Vaginal pH and a self-assessment of the symptoms will be assessed. The treatment consists of administration of intravaginal gel from an applicator filled from a tube, once daily for 12 weeks. All participants will self- administer the intravaginal gel once daily for 12 weeks.
Read the detailed description
Management of breast cancer involves systematic therapies including chemotherapy and endocrine therapy which can lead to vaginal atrophy (VA), caused by decreased levels of circulating estrogen to urinary and vaginal receptors. Due to the reduced estrogen production, less vaginal fluid is produced within the vagina and the mucosa becomes thinner and more fragile. This group of patients can not use estrogen treatment to reduce the symptoms of vaginal atrophy.
A previous study showed a significant reduction in the severity of the most bothersome VA symptoms and vaginal pH was improved (decreased) as well as increased percentage of superficial cells over a 12 week treatment period with Vagivital.
In this study all participants will self- administer the intravaginal gel once daily for 12 weeks.
- Conditions
- Vaginal Atrophy
- Being tested
- Vagivital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VagivitalDevice
Vagivital once Daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vagivital | Experimental | Vagivital once Daily for 12 weeks Receives: Device: Vagivital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of VA symptom
Change from baseline to Week 12 in severity of VA symptom (vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity) that has been self-identified by the subject as being the most bothersome to her.The VA Symptoms are graded from 0-3, where 0 = none and 3 = severe
Measured: 12 weeks
Secondary outcomes (11)
Change in Vaginal pH
Change from baseline to Week 4 in Vaginal pH
Measured: 4 weeks
Change in Vaginal pH
Change from baseline to Week 12 in Vaginal pH
Measured: 12 weeks
Change in severity of VA Symptom
Change from baseline to Week 4 in severity of the VA symptoms (vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity). The VA Symptoms are graded from 0-3, where 0 = none and 3 = severe
Measured: 4 weeks
Change in total score in Quality of Life evaluation parameters
Change from baseline to Week 12 in Quality of Life evaluation parameters Women's Health Questionnaire. Total Score (sum of the questions as recorded in the data management system (Yes, definitely=0, Yes, sometimes=1, No, not much=2 or No, not at all=3) except for question 7, 8, 10, 12 and 14 where the score opposite in points. Missing values are imputed using the mean of all recorded values. Analysis set ITT.
Measured: 12 weeks
Number of AEs and assessment of intensity, causality and seriousness of Advers Events
The adverse events will be classified as non-serious adverse event or serious adverse event (SAE), the intensity will be graded as mild, moderate or severe and causality will be classified as unlikely, possible and probably.
Measured: 14 weeks
Change in Blod pressure
Change from baseline to Week 4 in blood pressure
Measured: 4 weeks
Change in Blod pressure
Change from baseline to Week 12 in blood pressure
Measured: 12 weeks
Change in Heart rate
Change from baseline to Week 4 in heart rate
Measured: 4 weeks
Change in Heart rate
Change from baseline to Week 12 in heart rate
Measured: 12 weeks
Change in degree of vaginal atrophy
Change from baseline to Week 12 in the degree of vaginal atrophy. The assessment is made by okular gynocological examinations and graded mild, moderate and severe.
Measured: 12 weeks
Urine infections
Number of urine infections during the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start14 Jun 2019
- Primary completion10 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open single-armed study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aino Fianu Jonasson, MD, PhD, Principal investigator, Karolinska Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998722
- Sponsor's protocol ID
- Vagipep101
- Status last verified
- Nov 2020
- First submitted
- 24 May 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Single-arm Investigation to Evaluate the Use of VagiVital® for Treatment of Vaginal Atrophy in Cancer Patients Undergoing Adjuvant Aromatase Inhibitor Therapy - 12 Weeks Follow-up
- ClinicalTrials.gov ID
- NCT03998722
- Acronym / sponsor ID
- Vagipep101
- Conditions
- Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 26 Jun 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.
An open study to evaluate the ability of VagiVital in reducing the severity of moderate to severe symptoms of vaginal atrophy for women under treatment on adjuvant aromatase inhibitor therapy. Vaginal pH and a self-assessment of the symptoms will be assessed. The treatment consists of administration of intravaginal gel from an applicator filled from a tube, once daily for 12 weeks. All participants will self- administer the intravaginal gel once daily for 12 weeks.
Detailed description
Management of breast cancer involves systematic therapies including chemotherapy and endocrine therapy which can lead to vaginal atrophy (VA), caused by decreased levels of circulating estrogen to urinary and vaginal receptors. Due to the reduced estrogen production, less vaginal fluid is produced within the vagina and the mucosa becomes thinner and more fragile. This group of patients can not use estrogen treatment to reduce the symptoms of vaginal atrophy.
A previous study showed a significant reduction in the severity of the most bothersome VA symptoms and vaginal pH was improved (decreased) as well as increased percentage of superficial cells over a 12 week treatment period with Vagivital.
In this study all participants will self- administer the intravaginal gel once daily for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open single-armed study
| Arm | Type | Receives |
|---|---|---|
| Vagivital | Experimental | Device: VagivitalVagivital once Daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be a female, 18 years or older, who is willing to participate in the study as indicated by signing the informed consent.
- Women over the age of 18 who have been diagnosed with cancer and are currently taking adjuvant AI therapy who also complain of vaginal atrophy symptoms including vaginal dryness, vaginal itching, frequent urinary tract infections, or dyspareunia are candidates for this study. They also have to be sexually active or wanted to be so, but couldn´t because of problems with vaginal atrophy.
- Have one moderate to severe VA symptom (vaginal irritation and itching, vaginal dryness, dysuria, dyspareunia or presence of vaginal bleeding associated with sexual activity) that has been identified by the subject as being the most bothersome to her according to the scale presented in APPENDIX B.
- Be judged by the Principal Investigator as being in otherwise good health based on the medical evaluation performed at baseline. The medical evaluation findings must include:
- Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and at Visits 2 and 3.
Key exclusion criteria (20 listed)
- Be currently hospitalized.
- Have a history of ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
- Have a history of undiagnosed vaginal bleeding.
- Have an ongoing urogenital infection at the screening visit.
- Any contraindication to the gel (VagiVital) therapy and allergy to the use of any components of the investigational device.
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 |
|---|---|---|
| VagivitalVagivital once Daily for 12 weeks | Device | Vagivital |
Primary outcome
Change in severity of VA symptom
Time frame: 12 weeks
Change from baseline to Week 12 in severity of VA symptom (vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity) that has been self-identified by the subject as being the most bothersome to her.The VA Symptoms are graded from 0-3, where 0 = none and 3 = severe
11 secondary outcomes
Change in Vaginal pH
Time frame: 4 weeks
Change in Vaginal pH
Time frame: 12 weeks
Change in severity of VA Symptom
Time frame: 4 weeks
Change in total score in Quality of Life evaluation parameters
Time frame: 12 weeks
Number of AEs and assessment of intensity, causality and seriousness of Advers Events
Time frame: 14 weeks
Change in Blod pressure
Time frame: 4 weeks
Change in Blod pressure
Time frame: 12 weeks
Change in Heart rate
Time frame: 4 weeks
Change in Heart rate
Time frame: 12 weeks
Change in degree of vaginal atrophy
Time frame: 12 weeks
Urine infections
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Aino Fianu Jonasson, MD, PhD principal investigator
Karolinska Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagivital in people with Vaginal Atrophy, run by PepTonic Medical AB at 1 site in Sweden.
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 11 inclusion and 20 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: finished, as of the sponsor's last update on 13 Nov 2020. 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 Sweden. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in severity of VA symptom (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2020.