Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido

Bayer

Status and phase

Completed

Phase 2

Conditions

Libido

Treatments

Drug: Dehydroepiandrosterone, BAY86-5314

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00566384

310741 (Other Identifier)

2006-004397-27 (EudraCT Number)

91692

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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 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