Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptive… (NCT00566384) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido
Germany100 participantsStarted 2007-11
Plain-language 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 arousal component scores of the FSFI questionnaire from baseline to cycle 6 of the treatment with the study drug as compared to Placebo.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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 …
What they're measuring
1
FSDS questionnaire (sexual desire and arousal component scores)