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

Conditions: 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 disorder (FSD) associated with OC-use
MedDRA version: 9.1Level: LLTClassification code 10040477Term: Sexual dysfunction

Registration Number: EUCTR2006-004397-27-DE

Lead Sponsor: Bayer Schering Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

1.Signed and dated informed consent
2.Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive) at visit 1
3.Women on treatment with a monophasic combined oral contraceptive (COC) and suffering from reduced libido as a perceived side effect of the OC use (i.e.acquired OC-associated HSDD) for at least 3 months and willing to continue the particular OC that they have been using.
4.Value of 18 or below in the not weighted sum score of the sexual desire and arousal domain of the FSFI questionnaire at screening and baseline.
5.Sexual relationship with a sexually competent partner
6.Non-suspicious cervical smear taken at visit 1 or within the last 3 months before visit 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Female sexual dysfunction other than HSDD, such as sexual aversion/phobic disorder, sexual pain disorder/dyspareunia
2)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
3)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.
4)Presence or history of prodromi of a thrombosis (e.g., transient ischaemic attack, angina pectoris).
5)History of migraine with focal neurological symptoms.
6)Diabetes mellitus with vascular involvement.
7)Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
8)Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
9)Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
10)Presence or history of liver tumors (benign or malignant).
11)Known or suspected sex-steroid influenced malignancies (e.g., of the genital organs or the breasts)
12)Undiagnosed vaginal bleeding.
13)Known or suspected pregnancy.
14)Hypersensitivity to the active substances or to any of the excipients.