Vaginal AtrophyPhase 2OXYPEP002NCT01987804
Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women
A Phase 2 study testing Oxytocin 100 i.u. and Oxytocin 400 i.u. in people with Vaginal Atrophy, run by PepTonic Medical AB at 1 site in Sweden.
Trial summary
Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections . Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Oxytocin 100 i.u. and Oxytocin 400 i.u.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Jan 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to baseline.
- > 40 years of age.
- Moderate to severe symptoms of at least one of the following criteria of vulvar and vaginal atrophy associated with the menopause, according to the patient's self-assessement: vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or presence of vaginal bleeding associated with sexual activity.
- Atrophic mucosa according to the investigator's assessment.
- Signed Informed Consent.
Who cannot join
- 1. Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline.
- 2. Usage of any lubricant for intra-vaginal administration at baseline. 3. Vaginal bleeding of unknown origin. 4. Vaginal pH ≤ 5.0. 5. Any ongoing uro-genital infection within 7 days prior to baseline. 6. Body Mass Index (BMI) >30 kg/m2. 7. Systolic Blood Pressure > 150 mmHg and Diastolic Blood Pressure > 90 mmHg at baseline.
- 8. Any concurrent known or suspected tumor disease as judged by the investigator.
- 9. Clinically significant medical history (excluding medically well-controlled hypertension and hypercholesterolemia), abnormal findings from physical examinations, vital signs, cytology, histology, US examination of uterus and ovaries or laboratory analyses that may interfere with the trial objectives or compromise the safety of the patient as judged by the Investigator.
- 10. Concurrent and diagnosed nephrological or hepatic disorder 11. Diagnosed with HIV, Hepatitis B or C 12. Known or suspected drug or alcohol abuse, within 12 months prior to baseline.
- 13. Known or suspected allergy to any ingredient of the trial product. 14. Incapacity to perform trial procedures, as judged by the investigator. 15. Participation in any other interventional clinical trial within 3 months prior to baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo Controlled Single Centre Trial to Evaluate the Dose-relationship of the Effects of Vaginally Administered Oxytocin on the Vaginal Mucosal Membrane in Postmenopausal Women With Vaginal Atrophy
Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections . The mucosal epithelium shows signs of severe senile atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells . Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically via the posterior pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women, an effect which could be attributed either to the direct stimulation of new cell formation or to an increased production of other growth factors. The primary objective is to investigate the dose relationsship of topical administrated Vagitocin on the vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after baseline.
- Conditions
- Vaginal Atrophy
- Being tested
- Oxytocin 100 i.u., Oxytocin 400 i.u., Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin 100 i.u.Drug
Also called Vagoticin
Oxytocin 400 i.u.Drug
Also called Vagoticin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin 100 i.u. | Experimental | N=24 patients are administrated Oxytocin 100 i.u. vaginally Receives: Drug: Oxytocin 100 i.u. |
| Oxytocin 400 i.u. | Experimental | N=24 patients are administrated Oxytocin 400 i.u. vaginally Receives: Drug: Oxytocin 400 i.u. |
| Placebo | Placebo comparator | N=16 patients are administrated placebo vaginally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.
Change in percentage points of superficial cells from baseline visit (visit 1) to 7 weeks of treatment (Visit 3).
Measured: from baseline visit to 7 weeks of treatment
Secondary outcomes (1)
To investigate the safety and tolerability of topical Vagitocin treatment.
Change in percentage points of superficial cells from baseline visit to 2 (Visit 2) weeks of treatment.
Change in maturation value from baseline visit to 2 (Visit 2) and 7 (Visit 3) weeks of treatment.
Change in vaginal pH from baseline visit to 2 (Visit 2) and 7 (Visit 3) weeks of treatment.
Visual appearance of the vaginal mucosa after 2 (Visit 2) and 7 (Visit 3) weeks of treatment
- Patients´ self-assessment of the most bothersome symptomafter 2 (Visit 2), 7 (Visit 3), weeks of treatment and at the telephone follow-up after 9 weeks.
- Histological assessment after 2 (Visit 2) and 7 weeks (Visit 3) of treatment.
- Change in score in selected items of WHQ/SSP from baseline visit to 7 (Visit 3) weeks of treatment and at the telephone follow-up after 9 weeks.
Measured: From visit 2 to visit 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJan 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharma Consulting Group AB
- Responsible party
- Sponsor
- Investigators
- Aino F Jonasson, M.D, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987804
- Sponsor's protocol ID
- OXYPEP002
- Acronym
- OXYPEP002
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2013
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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
- A Double-blind, Placebo Controlled Single Centre Trial to Evaluate the Dose-relationship of the Effects of Vaginally Administered Oxytocin on the Vaginal Mucosal Membrane in Postmenopausal Women With Vaginal Atrophy
- ClinicalTrials.gov ID
- NCT01987804
- Acronym / sponsor ID
- OXYPEP002 / OXYPEP002
- Conditions
- Vaginal Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Pharma Consulting Group AB
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Nov 2013 (estimated)
- 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.
Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections . The mucosal epithelium shows signs of severe senile atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells . Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically via the posterior pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women, an effect which could be attributed either to the direct stimulation of new cell formation or to an increased production of other growth factors. The primary objective is to investigate the dose relationsship of topical administrated Vagitocin on the vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin 100 i.u. | Experimental | Drug: Oxytocin 100 i.u.N=24 patients are administrated Oxytocin 100 i.u. vaginally |
| Oxytocin 400 i.u. | Experimental | Drug: Oxytocin 400 i.u.N=24 patients are administrated Oxytocin 400 i.u. vaginally |
| Placebo | Placebo comparator | Drug: PlaceboN=16 patients are administrated placebo vaginally |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to baseline.
- > 40 years of age.
- Moderate to severe symptoms of at least one of the following criteria of vulvar and vaginal atrophy associated with the menopause, according to the patient's self-assessement: vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or presence of vaginal bleeding associated with sexual activity.
- Atrophic mucosa according to the investigator's assessment.
- Signed Informed Consent.
Key exclusion criteria (6 listed)
- 1. Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline.
- 2. Usage of any lubricant for intra-vaginal administration at baseline. 3. Vaginal bleeding of unknown origin. 4. Vaginal pH ≤ 5.0. 5. Any ongoing uro-genital infection within 7 days prior to baseline. 6. Body Mass Index (BMI) >30 kg/m2. 7. Systolic Blood Pressure > 150 mmHg and Diastolic Blood Pressure > 90 mmHg at baseline.
- 8. Any concurrent known or suspected tumor disease as judged by the investigator.
- 9. Clinically significant medical history (excluding medically well-controlled hypertension and hypercholesterolemia), abnormal findings from physical examinations, vital signs, cytology, histology, US examination of uterus and ovaries or laboratory analyses that may interfere with the trial objectives or compromise the safety of the patient as judged by the Investigator.
- 10. Concurrent and diagnosed nephrological or hepatic disorder 11. Diagnosed with HIV, Hepatitis B or C 12. Known or suspected drug or alcohol abuse, within 12 months prior to baseline.
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 100 i.u.Also: Vagoticin | Drug | Oxytocin 100 i.u. |
| Oxytocin 400 i.u.Also: Vagoticin | Drug | Oxytocin 400 i.u. |
| Placebo | Drug | Placebo |
Primary outcome
To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.
Time frame: from baseline visit to 7 weeks of treatment
Change in percentage points of superficial cells from baseline visit (visit 1) to 7 weeks of treatment (Visit 3).
1 secondary outcome
To investigate the safety and tolerability of topical Vagitocin treatment.
Time frame: From visit 2 to visit 7
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.
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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 F Jonasson, M.D, PhD principal investigator
Karolinska Institutet
1 site 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 100 i.u. and Oxytocin 400 i.u. 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 5 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: 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. 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?
To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane. (time frame: from baseline visit to 7 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 13 Nov 2020.