check_circleStudy Completed
Libido
Bayer Identifier:
91692
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy and safety of oral dehydroepiandrosterone as a concomitant therapy to oral contraceptives in women complaining of reduced libido
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
100Trial Dates
November 2007 - April 2009Phase
Phase 2Could I Receive a placebo
YesProducts
Dehydroepiandrosterone - DHEA (BAY86-5314)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Praxis Fr. Dr. Kirsten Kuhlmann | Berlin, 13357, Germany |
Completed | Praxis Hr. Dr. Karl-Heinz Belling | Berlin, 13086, Germany |
Completed | Bayer Pharma AG | Berlin, 13353, Germany |
Completed | Praxis Fr. Dr. Claudia Ehle | Berlin, 10627, Germany |
Completed | CRH Clinical Research Hamburg GmbH | Hamburg, 22143, Germany |
Completed | Praxis Fr. Dr. M. Weber u. Fr. Dr. vn der Gablentz | Berlin, 12435, Germany |
Completed | Dinox GmbH Berlin | Berlin, 10115, Germany |
Completed | Frauenarztpraxis Hr. Dr. H. Lindecke | Berlin, 10247, Germany |
Completed | Praxis Fr. Dr. Ursula Weingarten | Berlin, 10709, Germany |
Completed | emovis GmbH | Berlin, 10629, Germany |
Completed | Gemeinschaftspraxis Dr. R. Willroth & Dr. A. Novak | Berlin, 14195, Germany |
Primary Outcome
- FSDS questionnaire (sexual desire and arousal component scores)date_rangeTime Frame:at baseline and after Cycle 6enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Change from baseline period to cycle 6 in the number of satisfactory sexual eventsdate_rangeTime Frame:after Cycle 6enhanced_encryptionnoSafety Issue:
- FSFI questionnaire (absolute values and change from baseline) - All domainsdate_rangeTime Frame:Cycle 1, 3, 6 and follow-upenhanced_encryptionnoSafety Issue:
- FSDS-R questionnaire resultsdate_rangeTime Frame:Cycle 1, 3, 6 and follow-upenhanced_encryptionnoSafety Issue:
- FSEP questionnaire resultsdate_rangeTime Frame:Cycle 1, 3, 6 and follow-upenhanced_encryptionnoSafety Issue:
- PGWBI questionnaire resultsdate_rangeTime Frame:Cycle 1, 3, 6 and follow-upenhanced_encryptionnoSafety Issue:
- Serum hormone levels (SHBG, T, DHEA, DHEA-S)date_rangeTime Frame:Cycle 1, 3, 6 and follow-upenhanced_encryptionnoSafety Issue:
- Vaginal pHdate_rangeTime Frame:Cycle 1, 3, 6 and follow-upenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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