LibidoPhase 2NCT00566384
Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido
A Phase 2 study testing Dehydroepiandrosterone, BAY86-5314 in people with Libido, run by Bayer at 11 sites in Germany.
Trial summary
The purpose of the study is to evaluate the effectiveness of the study drug on the libido (sexual desire) of women who are taking oral contraceptives and who have experienced libido reductions as a side-effect of this contraceptive method The hypothesis is that there is superiority in the change in sexual desire and… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Libido
- What is being tested?
- Dehydroepiandrosterone, BAY86-5314
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 11 sitesGermany
- Study dates
- Nov 2007to Apr 2009
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Treatment with a oral contraceptive (OC) for at least 3 months and willing to continue the OC
- Loss of libido
- Sexual relationship with a sexually competent partner
Who cannot join
- Female sexual dysfunction other than HSDD, arousal and orgasmic disorder, such as sexual aversion/phobic disorder, sexual pain disorder/dyspareunia
- Hyperandrogenemic conditions, such as congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), Cushing's syndrome or signs of hyperandrogenism like severe hirsutism or severe acne
- Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
- Presence or history of prodromi of a thrombosis (e.g., transient ischaemic attack, angina pectoris).
- History of migraine with focal neurological symptoms.
- Diabetes mellitus with vascular involvement.
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- Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
- Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
- Presence or history of liver tumors (benign or malignant).
- Known or suspected sex-steroid influenced malignancies (e.g., of the genital organs or the breasts)
- Undiagnosed vaginal bleeding.
- Known or suspected pregnancy.
- Hypersensitivity to the active substances or to any of the excipients.
- Body-mass index (BMI ) more than 30.0 kg/m²
- Hypersensitivity to any of the study drug ingredients
- Any disease or condition that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
- Known current or history of alcohol or drug abuse
- Prohibited concomitant medication:
- Use of additional steroid hormones, anticoagulants (e.g., heparin, coumarin), antiepileptics (hydantoin derivates, e.g., phenytoin or carboxamide derivates, e.g., carbamazepin, oxcarbamazepin), other antiepileptics, (e.g., Felbamate, Topiramate), hypnotic and sedative (e.g., barbiturate derivates, primidone), tuberculostatics (e.g., rifampicin), oral antimycotics (e.g., griseofulvin, ketoconazole, itraconazole, fluconazol), virostatic agents (e.g., ritonavir), and products containing St. John's wort and continuous systemic use of antibiotics.
- Medication with influence on libido (e.g., antihypertensives like beta-adrenergic blocker, cholinesterase blocking agents), psychotropic drugs (e.g., antidepressants, neuroleptic agents, selective serotonin reuptake inhibitors [SSRIs]), lipid lowering drugs and H2 blockers.
- Intake of an experimental drug within 3 months prior to inclusion in the study
- Previous assignment to treatment (e.g., randomization) during this study
- Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site).
- Operation scheduled in the study period
- Abnormal laboratory values within the non-inclusion range
- Patient is in custody by order of an authority or a court of law
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Study site
Berlin, State of Berlin, 10115
Study site
Berlin, State of Berlin, 10247
Study site
Berlin, State of Berlin, 10627
Study site
Berlin, State of Berlin, 10629
Study site
Berlin, State of Berlin, 10709
Study site
Berlin, State of Berlin, 12435
Study site
Berlin, State of Berlin, 13086
Study site
Berlin, State of Berlin, 13353
Study site
Berlin, State of Berlin, 13357
Study site
Berlin, State of Berlin, 14195
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22143
About this study
Official title: Multi-center, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Daily Oral 100 mg Dehydroepiandrosterone (DHEA) Over 6 Treatment Cycles as a Concomitant Therapy to Oral Contraceptives (OC) to Alleviate Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With OC-use
The purpose of the study is to evaluate the effectiveness of the study drug on the libido (sexual desire) of women who are taking oral contraceptives and who have experienced libido reductions as a side-effect of this contraceptive method The hypothesis is that there is superiority in the change in sexual desire and arousal component scores of the FSFI questionnaire from baseline to cycle 6 of the treatment with the study drug as compared to Placebo.
- Conditions
- Libido
- Being tested
- Dehydroepiandrosterone, BAY86-5314, Placebo
- Keywords
- Loss of libido, Acquired, oral contraceptive -associated female sexual dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydroepiandrosterone, BAY86-5314Drug
Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
PlaceboDrug
Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Dehydroepiandrosterone, BAY86-5314 |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSDS questionnaire (sexual desire and arousal component scores)
Measured: at baseline and after Cycle 6
Secondary outcomes (7)
Change from baseline period to cycle 6 in the number of satisfactory sexual events
Measured: after Cycle 6
FSFI questionnaire (absolute values and change from baseline) - All domains
Measured: Cycle 1, 3, 6 and follow-up
FSDS-R questionnaire results
Measured: Cycle 1, 3, 6 and follow-up
FSEP questionnaire results
Measured: Cycle 1, 3, 6 and follow-up
PGWBI questionnaire results
Measured: Cycle 1, 3, 6 and follow-up
Serum hormone levels (SHBG, T, DHEA, DHEA-S)
Measured: Cycle 1, 3, 6 and follow-up
Vaginal pH
Measured: Cycle 1, 3, 6 and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LibidoStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566384
- Sponsor's protocol ID
- 91692
- Other IDs
- 310741, 2006-004397-27
- Status last verified
- Nov 2014
- First submitted
- 29 Nov 2007
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Daily Oral 100 mg Dehydroepiandrosterone (DHEA) Over 6 Treatment Cycles as a Concomitant Therapy to Oral Contraceptives (OC) to Alleviate Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With OC-use
- ClinicalTrials.gov ID
- NCT00566384
- Acronym / sponsor ID
- 91692
- Conditions
- Libido
- Keywords
- Loss of libido, Acquired, oral contraceptive -associated female sexual dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 3 Dec 2007 (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 the study is to evaluate the effectiveness of the study drug on the libido (sexual desire) of women who are taking oral contraceptives and who have experienced libido reductions as a side-effect of this contraceptive method The hypothesis is that there is superiority in the change in sexual desire and arousal component scores of the FSFI questionnaire from baseline to cycle 6 of the treatment with the study drug 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 |
|---|---|---|
| Arm 1 | Active comparator | Drug: Dehydroepiandrosterone, BAY86-5314 |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Treatment with a oral contraceptive (OC) for at least 3 months and willing to continue the OC
- Loss of libido
- Sexual relationship with a sexually competent partner
Key exclusion criteria (27 listed)
- Female sexual dysfunction other than HSDD, arousal and orgasmic disorder, such as sexual aversion/phobic disorder, sexual pain disorder/dyspareunia
- Hyperandrogenemic conditions, such as congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), Cushing's syndrome or signs of hyperandrogenism like severe hirsutism or severe acne
- Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
- Presence or history of prodromi of a thrombosis (e.g., transient ischaemic attack, angina pectoris).
- History of migraine with focal neurological symptoms.
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 |
|---|---|---|
| Dehydroepiandrosterone, BAY86-5314Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks | Drug | Arm 1 |
| PlaceboTreatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks | Drug | Arm 2 |
Primary outcome
FSDS questionnaire (sexual desire and arousal component scores)
Time frame: at baseline and after Cycle 6
7 secondary outcomes
Change from baseline period to cycle 6 in the number of satisfactory sexual events
Time frame: after Cycle 6
FSFI questionnaire (absolute values and change from baseline) - All domains
Time frame: Cycle 1, 3, 6 and follow-up
FSDS-R questionnaire results
Time frame: Cycle 1, 3, 6 and follow-up
FSEP questionnaire results
Time frame: Cycle 1, 3, 6 and follow-up
PGWBI questionnaire results
Time frame: Cycle 1, 3, 6 and follow-up
Serum hormone levels (SHBG, T, DHEA, DHEA-S)
Time frame: Cycle 1, 3, 6 and follow-up
Vaginal pH
Time frame: Cycle 1, 3, 6 and follow-up
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 2 Dec 2014.
- Click here and search for Bayer products information provided by the EMALink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
11 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 Dehydroepiandrosterone, BAY86-5314 in people with Libido, run by Bayer at 11 sites in Germany.
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 3 inclusion and 27 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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?
FSDS questionnaire (sexual desire and arousal component scores) (time frame: at baseline and after Cycle 6). 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 2 Dec 2014.