Female Sexual DysfunctionPhase 2NCT02229721
Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women
A Phase 2 study testing Syntocinon Nasalspray in people with Female Sexual Dysfunction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to determine whether intranasal oxytocin is effective in comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal women. 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
- Female Sexual Dysfunction
- What is being tested?
- Syntocinon Nasalspray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2012to Oct 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to attempt sexual intercourse and/ or masturbation at least two times per week
- Ongoing relationship for at least 3 months
- Female subjects aging 40 years and more, Male subjects must be older than 18
- The participation in this study should be of free choice to male partners
- Willingness to perform a pregnancy test every month (for pre-menopausal subjects)
- Willingness to use contraception during the study period (for pre-menopausal subjects)
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- Normal findings in the urogenital tract unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Primary sexual dysfunction
- sexual abuse
- severe psychiatric diseases
- untreated conditions and medication intake with associated reduction of sexual function.
- In male partners: any severe andrological or related medical problem.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
Vienna, State of Vienna, 1090
About this study
Official title: Female Sexual Dysfunction in the Menopause: Effect of Intranasal Oxytocin Administration on Sexual Function and Activity
The purpose of this study is to determine whether intranasal oxytocin is effective in comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal women.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Syntocinon Nasalspray, Placebo Nasalspray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon NasalsprayDrug
Also called Oxytocin
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
Placebo NasalsprayDrug
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Syntocinon Nasalspray 32 IU | Active comparator | Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly. Receives: Drug: Syntocinon Nasalspray; Drug: Placebo Nasalspray |
| Placebo Nasalspray | Placebo comparator | Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly. Receives: Drug: Syntocinon Nasalspray; Drug: Placebo Nasalspray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function
Assessment by standardized questionnaires including Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Activity Record (SAR), and Sexual Interest and Desire Inventory-Female (SIDI-F).
Measured: 22 weeks
Secondary outcomes (1)
Hamilton Depression Scale (HDS)
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Leadiant Biosciences, Inc.
- Responsible party
- Principal investigator, Dana Muin, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229721
- Sponsor's protocol ID
- 2011-001310-34
- Status last verified
- Aug 2014
- First submitted
- 27 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Muin DA, Sheikh Rezaei S, Tremmel-Scheinost M, Salama M, Luger A, Wolzt M, Husslein PW, Bayerle-Eder M. Men's sexual response to female partner's intranasal oxytocin administration for hypoactive sexual desire disorder: an open prospective cohort study. Fertil Steril. 2017 Mar;107(3):781-787.e3. doi: 10.1016/j.fertnstert.2016.12.003. Epub 2017 Feb 8.
PubMed 28189292Muin DA, Wolzt M, Marculescu R, Sheikh Rezaei S, Salama M, Fuchs C, Luger A, Bragagna E, Litschauer B, Bayerle-Eder M. Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial. Fertil Steril. 2015 Sep;104(3):715-23.e4. doi: 10.1016/j.fertnstert.2015.06.010. Epub 2015 Jul 4.
PubMed 26151620
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Sexual Dysfunction in the Menopause: Effect of Intranasal Oxytocin Administration on Sexual Function and Activity
- ClinicalTrials.gov ID
- NCT02229721
- Acronym / sponsor ID
- 2011-001310-34
- Conditions
- Female Sexual Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Leadiant Biosciences, Inc.
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Sep 2014 (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.
The purpose of this study is to determine whether intranasal oxytocin is effective in comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syntocinon Nasalspray 32 IU | Active comparator | Drug: Syntocinon Nasalspray, Drug: Placebo NasalsprayOver 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks. The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly. |
| Placebo Nasalspray | Placebo comparator | Drug: Syntocinon Nasalspray, Drug: Placebo NasalsprayOver 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks. The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willingness to attempt sexual intercourse and/ or masturbation at least two times per week
- Ongoing relationship for at least 3 months
- Female subjects aging 40 years and more, Male subjects must be older than 18
- The participation in this study should be of free choice to male partners
- Willingness to perform a pregnancy test every month (for pre-menopausal subjects)
Key exclusion criteria (5 listed)
- Primary sexual dysfunction
- sexual abuse
- severe psychiatric diseases
- untreated conditions and medication intake with associated reduction of sexual function.
- In male partners: any severe andrological or related medical problem.
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 |
|---|---|---|
| Syntocinon NasalsprayAlso: OxytocinOver 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks. The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly. | Drug | Placebo Nasalspray, Syntocinon Nasalspray 32 IU |
| Placebo NasalsprayOver 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks. The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly. | Drug | Placebo Nasalspray, Syntocinon Nasalspray 32 IU |
Primary outcome
Female Sexual Function
Time frame: 22 weeks
Assessment by standardized questionnaires including Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Activity Record (SAR), and Sexual Interest and Desire Inventory-Female (SIDI-F).
1 secondary outcome
Hamilton Depression Scale (HDS)
Time frame: 22 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 1 Sep 2014.
- Derived from this study: PubMed 28189292Muin DA, Sheikh Rezaei S, Tremmel-Scheinost M, Salama M, Luger A, Wolzt M, Husslein PW, Bayerle-Eder M. Men's sexual response to female partner's intranasal oxytocin administration for hypoactive sexual desire disorder: an open prospective cohort study. Fertil Steril. 2017 Mar;107(3):781-787.e3. doi: 10.1016/j.fertnstert.2016.12.003. Epub 2017 Feb 8.
- Derived from this study: PubMed 26151620Muin DA, Wolzt M, Marculescu R, Sheikh Rezaei S, Salama M, Fuchs C, Luger A, Bragagna E, Litschauer B, Bayerle-Eder M. Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial. Fertil Steril. 2015 Sep;104(3):715-23.e4. doi: 10.1016/j.fertnstert.2015.06.010. Epub 2015 Jul 4.
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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.
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 Syntocinon Nasalspray in people with Female Sexual Dysfunction, run by Medical University of Vienna at 1 site in Austria.
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 5 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 1 Sep 2014. 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 Austria. 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?
Female Sexual Function (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229721, which also lists 2 linked publications.
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 1 Sep 2014.