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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
Unnamed facility
Hamburg, Hamburg, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
FSDS questionnaire (sexual desire and arousal component scores)
Time frame: at baseline and after Cycle 6
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
...and 1 more locations