Vulvovaginal AtrophyPhase 2NCT04629885
Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms
A Phase 2 study testing Oxytocin 400 IU vaginal gel in people with Vulvovaginal Atrophy, run by PepTonic Medical AB at 3 sites in Sweden.
Trial summary
A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts: The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Oxytocin 400 IU vaginal gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 3 sitesSweden
- Study dates
- 3 May 2016to 3 May 2017
- Phase
- Phase 2
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 40-65 years at the time of screening, who are willing to participate in the study as indicated by signing the informed consent.
- Postmenopausal women with at least 24 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks ago.
- Have ≤ 5% superficial cells in vaginal smear cytology at screening.
- Have a vaginal pH > 5.0 at screening.
- Have one moderate to severe vulvovaginal atrophy symptom (vulvar/vaginal irritation and itching, vaginal dryness, dysuria, dyspareunia or presence of vaginal bleeding associated with vaginal sexual activity) that has been identified by the subject as being the most bothersome to her.
- Have a body mass index (BMI) ≤32 kg/m2.
Show all 9Show fewer
- Be judged by the Principal Investigator or Sub-investigator as being in otherwise good health based on a pre-study medical evaluation performed within 21 days prior to the initial dose of study medication. The medical evaluation findings must include a) a normal or clinically non-significant finding at physical examination, b) a normal or clinically non-significant heart rate, c) a mean 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 mmHg (systolic) and ≤ 90 (diastolic) mmHg are suitable for inclusion, d) a normal or clinically non-significant finding at gynaecological examination, e) a normal mammography (no masses or other diagnosed findings suspected of being malignant) that has been performed within 36 months prior to initial dose of study medication, f) a normal or clinically non-significant finding at clinical breast examination (no masses or other findings suspected of being malignant), g) an acceptable Papanicolaou ("Pap") smear for subjects with an intact uterus and cervix (no dysplastic or malignant cells), h) laboratory values within normal limits or with non-significant deviations from normal values.
- Have an endometrial thickness of <4 mm as determined by vaginal ultrasonography, in women with an intact uterus.
- Be willing to abstain from vaginal 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
- Currently hospitalized.
- Have a history or 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 had or have any known or suspected tumor disease that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
- Have a history of endometrial hyperplasia or uterine/endometrial, breast or ovarian cancer.
- Have a history of undiagnosed vaginal bleeding.
- Have an ongoing urogenital infection in spite of treatment at the randomization visit.
Show all 15Show fewer
- Any contraindication to oxytocin therapy and allergy to the use of oxytocin and any components of the investigational drugs.
- Have a history of drug and/or alcohol abuse within one year of start of study.
- Have used any prescription or over-the-counter medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to the screening visit.
- Have used any type of vaginal lubricants and moisturizers within 24 hours prior to the screening visit.
- Have used estrogen alone or estrogen/progestin for any of the following time periods: a) vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to the screening visit, b) transdermal estrogen alone or estrogen/progestin products including percutaneous estrogen gels for at least 12 weeks prior to the screening visit, c) oral estrogen and/or progestin therapy within 12 weeks prior to the screening visit, d) intrauterine progestin therapy within 12 weeks prior to the screening visit, e) progestin implants and estrogen alone injectable drug therapy within 12 weeks prior to the screening visit, f) estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to the screening visit.
- Have any reason, which in the opinion of the Principal Investigator or Sub-Investigator would prevent the subject from safely participating in the study or complying with protocol requirements.
- Have participated in another clinical study within 90 days prior to screening, have received an investigational drug within three months prior to the initial dose of study medication, or be likely to participate in another clinical study or receive another investigational medication during the study.
- Have contraindication to any planned study procedure.
- Pregnancy.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Kvinnoforskningsenheten K59, Karolinska Universitetssjukhuset
Huddinge, 14186
Kvinnokliniken, Norrlands Universitetssjukhus
Umeå, 90185
Kvinnokliniken, Akademiska sjukhuset
Uppsala, 75185
About this study
Official title: A Phase 2b, Double-blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the 12-week Efficacy of Vagitocin in Postmenopausal Women With Symptoms of Vulvovaginal Atrophy
A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts:
- The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms.
- The exploratory part of the study investigates the efficacy and safety of the IMP, intravaginally administered in a laminate tube, on postmenopausal women with vulvovaginal atrophy symptoms.
Read more
A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients.
In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects receiving IMP and 10 patients receiving placebo, in laminate tubes.
The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit 0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All patients self-administer the IMP once daily for 12 weeks.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Oxytocin 400 IU vaginal gel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin 400 IU vaginal gelDrug
Also called Vagitocin
PlaceboDrug
Also called Placebo (for Vagitocin)
Matching placebo gel with identical appearance to the test product, used as reference treatment.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin 400 IU | Experimental | 1mL Oxytocin 400 IU vaginal gel once daily for 12 weeks Receives: Drug: Oxytocin 400 IU vaginal gel |
| Placebo | Placebo comparator | 1mL Placebo vaginal gel once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of the most bothersome VVA symptom.
Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity [yes/no]) that has been self-identified by the subject as being the most bothersome to her at baseline.
Measured: Baseline and after 12 weeks of treatment.
Secondary outcomes (13)
Change in vaginal pH
Change in vaginal pH (decrease is positive).
Measured: Baseline and 12 weeks of treatment.
Change in % superficial cells
Change in % superficial cells in vaginal smear (increase is positive).
Measured: Baseline and 12 weeks of treatment.
Change in maturation value
Change in maturation value (MV) (increase is positive). Maturation value is calculated using the percentage of parabasal cells, intermediate cells, and superficial cells in vaginal smear.
Measured: Baseline and 12 weeks of treatment.
Change in summary score for the vulvovaginal atrophy symptoms.
Change in summary score for the VVA symptoms vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness and dysuria (decrease is positive).
Measured: Baseline and 12 weeks of treatment.
Change in severity of the most bothersome VVA symptom.
Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity [yes/no]) that has been self-identified by the subject as being the most bothersome to her at baseline.
Measured: Baseline and 4 weeks of treatment.
Change in % superficial cells
Change in % superficial cells in vaginal smear (increase is positive).
Measured: Baseline and 4 weeks of treatment.
Change in vaginal pH
Change in vaginal pH (decrease is positive).
Measured: Baseline and 4 weeks of treatment.
Change in % parabasal cells
Change in % parabasal cells (decrease is positive).
Measured: Baseline and 4 and 12 weeks of treatment.
Change in maturation value
Change in maturation value (MV) (increase is positive). Maturation value is calculated using the percentage of parabasal cells, intermediate cells, and superficial cells in vaginal smear.
Measured: Baseline and 4 weeks of treatment.
Change in severity of the most bothersome VVA symptom.
Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity [yes/no]) that has been self-identified by the subject as being the most bothersome to her at baseline.
Measured: Baseline and 4 and 12 weeks of treatment.
Change in Quality of Life evaluation parameters.
Change in Quality of Life evaluation parameters.
Measured: Baseline and 12 weeks of treatment
Change in body weight.
Change in body weight.
Measured: Baseline and 12 weeks of treatment
Change over time of clinical safety data.
Change over time of clinical safety data (adverse events, vital signs, physical, gynecological and breast examination findings, laboratory tests, transvaginal ultrasound and pap smear).
Measured: Baseline and up to 14 weeks after first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start3 May 2016
- Primary completion3 May 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aino Fianu Jonasson, MD, Principal investigator, Kvinnoforskningsenheten K59, Karolinska Universitetssjukhuset, Huddinge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629885
- Sponsor's protocol ID
- OXYPEP202
- Other IDs
- 2016-000158-36, 2016
- Status last verified
- Nov 2020
- First submitted
- 8 May 2017
- Last updated
- 16 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 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Double-blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the 12-week Efficacy of Vagitocin in Postmenopausal Women With Symptoms of Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT04629885
- Acronym / sponsor ID
- OXYPEP202
- Conditions
- Vulvovaginal Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Study start
- 3 May 2016 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 16 Nov 2020 (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.
A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts:
- The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms.
- The exploratory part of the study investigates the efficacy and safety of the IMP, intravaginally administered in a laminate tube, on postmenopausal women with vulvovaginal atrophy symptoms.
A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients.
In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects receiving IMP and 10 patients receiving placebo, in laminate tubes.
The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit 0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All patients self-administer the IMP once daily for 12 weeks.
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 400 IU | Experimental | Drug: Oxytocin 400 IU vaginal gel1mL Oxytocin 400 IU vaginal gel once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo1mL Placebo vaginal gel once daily for 12 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females aged 40-65 years at the time of screening, who are willing to participate in the study as indicated by signing the informed consent.
- Postmenopausal women with at least 24 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks ago.
- Have ≤ 5% superficial cells in vaginal smear cytology at screening.
- Have a vaginal pH > 5.0 at screening.
- Have one moderate to severe vulvovaginal atrophy symptom (vulvar/vaginal irritation and itching, vaginal dryness, dysuria, dyspareunia or presence of vaginal bleeding associated with vaginal sexual activity) that has been identified by the subject as being the most bothersome to her.
Key exclusion criteria (15 listed)
- Currently hospitalized.
- Have a history or 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 had or have any known or suspected tumor disease that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
- Have a history of endometrial hyperplasia or uterine/endometrial, breast or ovarian cancer.
- Have a history of undiagnosed vaginal bleeding.
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 |
|---|---|---|
| Oxytocin 400 IU vaginal gelAlso: Vagitocin | Drug | Oxytocin 400 IU |
| PlaceboAlso: Placebo (for Vagitocin)Matching placebo gel with identical appearance to the test product, used as reference treatment. | Drug | Placebo |
Primary outcome
Change in severity of the most bothersome VVA symptom.
Time frame: Baseline and after 12 weeks of treatment.
Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity [yes/no]) that has been self-identified by the subject as being the most bothersome to her at baseline.
13 secondary outcomes
Change in vaginal pH
Time frame: Baseline and 12 weeks of treatment.
Change in % superficial cells
Time frame: Baseline and 12 weeks of treatment.
Change in maturation value
Time frame: Baseline and 12 weeks of treatment.
Change in summary score for the vulvovaginal atrophy symptoms.
Time frame: Baseline and 12 weeks of treatment.
Change in severity of the most bothersome VVA symptom.
Time frame: Baseline and 4 weeks of treatment.
Change in % superficial cells
Time frame: Baseline and 4 weeks of treatment.
Change in vaginal pH
Time frame: Baseline and 4 weeks of treatment.
Change in % parabasal cells
Time frame: Baseline and 4 and 12 weeks of treatment.
Change in maturation value
Time frame: Baseline and 4 weeks of treatment.
Change in severity of the most bothersome VVA symptom.
Time frame: Baseline and 4 and 12 weeks of treatment.
Change in Quality of Life evaluation parameters.
Time frame: Baseline and 12 weeks of treatment
Change in body weight.
Time frame: Baseline and 12 weeks of treatment
Change over time of clinical safety data.
Time frame: Baseline and up to 14 weeks after first dose.
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 16 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Vulvovaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
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 principal investigator
Kvinnoforskningsenheten K59, Karolinska Universitetssjukhuset, Huddinge
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin 400 IU vaginal gel in people with Vulvovaginal Atrophy, run by PepTonic Medical AB at 3 sites 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 9 inclusion and 15 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 16 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 3 sites 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. 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 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.
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 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 the most bothersome VVA symptom. (time frame: Baseline and after 12 weeks of treatment.). 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 16 Nov 2020.