Vaginal AtrophyPhase 2NCT01975129
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
A Phase 2 study testing Vagitocin in people with Vaginal Atrophy, run by PepTonic Medical AB at 1 site in Sweden.
Trial summary
This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Vagitocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Feb 2014
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women with vaginal atrophy as judged by the investigator
- Willing to participate in the study as indicated by signing the informed consent
- Healthy post-menopausal women between the ages of 40 and 70 years, inclusive
- Body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2
- Judged by the Investigator to be healthy on the basis of medical evaluation
Who cannot join
- Hospitalized subjects
- Symptoms of any significant acute illnesses at the screening visit
- History of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product)
- Known history of sensitivity to oxytocin or related derivatives
- Follicle-stimulating hormone level < 40 pmol/mL
- Known history of narcotic addiction, drug abuse or alcoholism
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- Simultaneously participate in another clinical study
- Use of any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline
- Uncontrolled hypertension and/or hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy
This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer Vagitocin intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. The % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.
- Conditions
- Vaginal Atrophy
- Being tested
- Vagitocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VagitocinDrug
Also called Oxytocin gel 400 International Units
| Study group | Role | What they receive |
|---|---|---|
| Vagitocin (Oxytocin) | Experimental | Not described Receives: Drug: Vagitocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin plasma levels
Oxytocin plasma levels after intravaginal and intravenous administration
Measured: Day 1 to 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aino Fianu Jonasson, MD Ass Prof, Principal investigator, Karolinska University Hopsital, Womens Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975129
- Sponsor's protocol ID
- OXYPEP003
- Status last verified
- May 2015
- First submitted
- 28 Oct 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy
- ClinicalTrials.gov ID
- NCT01975129
- Acronym / sponsor ID
- OXYPEP003
- Conditions
- Vaginal Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 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.
This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer Vagitocin intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. The % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagitocin (Oxytocin) | Experimental | Drug: Vagitocin |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post-menopausal women with vaginal atrophy as judged by the investigator
- Willing to participate in the study as indicated by signing the informed consent
- Healthy post-menopausal women between the ages of 40 and 70 years, inclusive
- Body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2
- Judged by the Investigator to be healthy on the basis of medical evaluation
Key exclusion criteria (9 listed)
- Hospitalized subjects
- Symptoms of any significant acute illnesses at the screening visit
- History of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product)
- Known history of sensitivity to oxytocin or related derivatives
- Follicle-stimulating hormone level < 40 pmol/mL
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 |
|---|---|---|
| VagitocinAlso: Oxytocin gel 400 International Units | Drug | Vagitocin (Oxytocin) |
Primary outcome
Oxytocin plasma levels
Time frame: Day 1 to 26
Oxytocin plasma levels after intravaginal and intravenous administration
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 28 May 2015.
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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 Ass Prof principal investigator
Karolinska University Hopsital, Womens Health
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 Vagitocin 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 9 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 28 May 2015. 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.
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?
Oxytocin plasma levels (time frame: Day 1 to 26). 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 28 May 2015.