PostmenopausePhase 2NCT01432470
Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women
A Phase 2 study testing Oxytocin in people with Postmenopause and Vaginal Atrophy, run by PepTonic Medical AB at 3 sites in 2 countries.
Trial summary
Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful. These symptoms combined are known as vaginal atrophy. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Postmenopause, Vaginal Atrophy
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2010to Jun 2011
- 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
- Signed Informed Consent
- at least 40 years of age
- naturally postmenopausal women, completely without menstrual bleedings for at least four years prior to screening.
- FSH plasma levels at least 40 IU/L and 17β-estradiol levels less than 70pmol/L
- Vaginal pH more than 5.0
- BMI at most 29 kg/m2
- Vaginal atrophy verified by cytological assessment of the vaginal mucosal epithelium. Vaginal atrophy is defined as at most 5% of superficial cells.
Who cannot join
- Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to screening.
- Usage of any lubricant for intra-vaginal administration at inclusion
- Any condition that is a contraindication to treatment with sex steroids
- Vaginal bleeding of unknown origin
- Any untreated urogenital infection within 7 days prior to inclusion
- Any prior or concurrent malignant disease or endometrial hyperplasia
Show all 15Show fewer
- Cervical cytology at least CIN 1 assessed during screening
- Clinically significant medical history (excluding medically well-controlled hypertension and hypercholesterolemia), findings from physical examinations, vital signs, cytology, histology or laboratory analyses that may interfere with the study objectives or compromise the safety of the subject as judged by the Investigator.
- Systolic Blood Pressure at least 140 mmHg or Diastolic Blood Pressure at least 90 mmHg at screening
- Participation in any other interventional clinical trial within 3 months prior to screening
- Known or suspected drug or alcohol abuse, within 12 months prior to screening
- Concurrent and diagnosed nephrologic or hepatic disorder
- Diagnosed with HIV, Hepatitis B or C
- Known or suspected allergy to any ingredient of the study product
- Incapacity to perform study procedures, as judged by the Investigator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites
Karolinska University Hospital-Huddinge
Huddinge, SE-141 86
Uppsala University Hospital
Uppsala, SE-751 85
United Kingdom1 site
Northwick Park & St Marks Hospital NHS Trust
Harrow Middlesex, HA1 3UJ
About this study
Official title: A Double-blind, Placebo Controlled Multi-centre Study to Evaluate the Effects of Topical Oxytocin on Vaginal Atrophy in Postmenopausal Women
Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful. These symptoms combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic 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 atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells.
Estrogen treatment either as hormone replacement therapy or topical application is a common treatment for vaginal atrophy. However, some women experience adverse reactions such as uterine bleeding, perineal pain and breast pain and many women are also reluctant to use estrogens due to a general negative view to this topic in the society.
Read more
Oxytocin is a peptide hormone, which is normally released into the circulation via the pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women.
Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation, topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was applied daily for seven days. The results indicated that for subjects receiving topical oxytocin the vaginal atrophy assessed by histological examination was reversed after treatment. A similar effect was not seen in the placebo group, which indicated a difference between placebo and active treatment. However, the limited number of exposed subjects in this pilot study necessitates a larger study in order to generate conclusive proof of concept data for the effects of oxytocin on vaginal atrophy.
Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal women are left without an effective remedy. Hence, there is a need for alternative non-estrogenic treatments of this indication. The present study is aiming to investigate the efficacy of topical oxytocin in the treatment of vaginal atrophy.
The main objective of this study is to investigate if topical oxytocin can reverse vaginal atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo.
- Conditions
- Postmenopause, Vaginal Atrophy
- Being tested
- Oxytocin, Placebo
- Keywords
- vaginal atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Gel for intravaginal use, 600 IU once per day for 2 weeks followed by 600 IU twice a week for ten weeks
PlaceboDrug
Gel for intravaginal use of identical appearance as active substance, once per day for two weeks followed by twice a week for ten weeks
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin, Intravaginal administration | Experimental | Not described Receives: Drug: Oxytocin |
| Placebo, Intravaginal administration | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maturation Value (MV)
The MV describes the change in percentage of superficial cells (Meisels A. The Maturation Value. Acta Cytol. 1967, Jul-Aug;11(4):249)
Measured: 12 weeks of oxytocin treatment as compared to placebo
Secondary outcomes (9)
Vaginal Atrophy
Atrophy in histological biopsies is assessed by a 4-grade scale
Measured: 12 weeks
Quality of Life
Using a standardized QoL form
Measured: 2 and 12 weeks
The Maturation Value
Same as primary outcome but after 2 weeks treatment
Measured: 2 weeks
Vaginal pH
Measured: 2 and 12 weeks
Concentration of Oxytocin in serum
The purpose of the evaluation is only to evaluate the systemic uptake. No other PK variables than the concentration are calculated.
Measured: 0-60 min after drug admin.
Clinician evaluation of vaginal mucosal appearance
Evaluation of seven different features, where every feature is assessed by a 4-grade scale.
Measured: 2 and 12 weeks
Laboratory assessments
Clinical Chemistry, Haematology, Urine analysis, Cervical cytology,Endometrial Histology
Measured: 2 and 12 weeks
Concentration of 17 beta-estradiol in serum
Measured: 12 weeks
Vital signs
Heart rate and blood pressure
Measured: 2 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432470
- Sponsor's protocol ID
- OxyPeP-001
- Status last verified
- Sep 2011
- First submitted
- 16 Aug 2010
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled Multi-centre Study to Evaluate the Effects of Topical Oxytocin on Vaginal Atrophy in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01432470
- Acronym / sponsor ID
- OxyPeP-001
- Conditions
- Postmenopause, Vaginal Atrophy
- Keywords
- vaginal atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Sep 2011 (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 dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful. These symptoms combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic 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 atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells.
Estrogen treatment either as hormone replacement therapy or topical application is a common treatment for vaginal atrophy. However, some women experience adverse reactions such as uterine bleeding, perineal pain and breast pain and many women are also reluctant to use estrogens due to a general negative view to this topic in the society.
Oxytocin is a peptide hormone, which is normally released into the circulation via the pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women.
Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation, topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was applied daily for seven days. The results indicated that for subjects receiving topical oxytocin the vaginal atrophy assessed by histological examination was reversed after treatment. A similar effect was not seen in the placebo group, which indicated a difference between placebo and active treatment. However, the limited number of exposed subjects in this pilot study necessitates a larger study in order to generate conclusive proof of concept data for the effects of oxytocin on vaginal atrophy.
Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal women are left without an effective remedy. Hence, there is a need for alternative non-estrogenic treatments of this indication. The present study is aiming to investigate the efficacy of topical oxytocin in the treatment of vaginal atrophy.
The main objective of this study is to investigate if topical oxytocin can reverse vaginal atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin, Intravaginal administration | Experimental | Drug: Oxytocin |
| Placebo, Intravaginal administration | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent
- at least 40 years of age
- naturally postmenopausal women, completely without menstrual bleedings for at least four years prior to screening.
- FSH plasma levels at least 40 IU/L and 17β-estradiol levels less than 70pmol/L
- Vaginal pH more than 5.0
Key exclusion criteria (15 listed)
- Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to screening.
- Usage of any lubricant for intra-vaginal administration at inclusion
- Any condition that is a contraindication to treatment with sex steroids
- Vaginal bleeding of unknown origin
- Any untreated urogenital infection within 7 days prior to inclusion
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 |
|---|---|---|
| OxytocinGel for intravaginal use, 600 IU once per day for 2 weeks followed by 600 IU twice a week for ten weeks | Drug | Oxytocin, Intravaginal administration |
| PlaceboGel for intravaginal use of identical appearance as active substance, once per day for two weeks followed by twice a week for ten weeks | Drug | Placebo, Intravaginal administration |
Primary outcome
The Maturation Value (MV)
Time frame: 12 weeks of oxytocin treatment as compared to placebo
The MV describes the change in percentage of superficial cells (Meisels A. The Maturation Value. Acta Cytol. 1967, Jul-Aug;11(4):249)
9 secondary outcomes
Vaginal Atrophy
Time frame: 12 weeks
Quality of Life
Time frame: 2 and 12 weeks
The Maturation Value
Time frame: 2 weeks
Vaginal pH
Time frame: 2 and 12 weeks
Concentration of Oxytocin in serum
Time frame: 0-60 min after drug admin.
Clinician evaluation of vaginal mucosal appearance
Time frame: 2 and 12 weeks
Laboratory assessments
Time frame: 2 and 12 weeks
Concentration of 17 beta-estradiol in serum
Time frame: 12 weeks
Vital signs
Time frame: 2 and 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 Sep 2011.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Postmenopause and Vaginal Atrophy, run by PepTonic Medical AB at 3 sites in 2 countries.
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 7 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 13 Sep 2011. 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, United Kingdom. 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?
The Maturation Value (MV) (time frame: 12 weeks of oxytocin treatment as compared to placebo). 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 Sep 2011.