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

NCT ID: NCT00566384

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-04-30

Brief 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.

Conditions

Libido

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: ACTIVE_COMPARATOR

Dehydroepiandrosterone, BAY86-5314

Intervention Type: DRUG

Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks

Interventions

Dehydroepiandrosterone, BAY86-5314

Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks

Intervention Type: DRUG

Placebo

Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Hamburg, City state of Hamburg, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Countries

Germany

Related Links

http://www.clinicaltrialsregister.eu

Click here and search for Bayer products information provided by the EMA

Other Identifiers

310741

Identifier Type: OTHER

Identifier Source: secondary_id

2006-004397-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

91692

Identifier Type: -

Identifier Source: org_study_id