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

Purpose

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.

Condition	Intervention	Phase
Decreased Libido	Drug: Dehydroepiandrosterone Drug: Placebo	Phase II

ChemIDplus related topics:

Dehydroepiandrosterone sulfate Prasterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	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

Further study details as provided by Bayer:

Primary Outcome Measures:

FSDS questionnaire (sexual desire and arousal component scores) [ Time Frame: at baseline and after 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline period to cycle 6 in the number of satisfactory sexual events [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
FSFI questionnaire (absolute values and change from baseline) - All domains [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
FSDS-R questionnaire results [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
FSEP questionnaire results [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
PGWBI questionnaire results [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
Serum hormone levels (SHBG, T, DHEA, DHEA-S) [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
Vaginal pH [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Dehydroepiandrosterone Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
Arm 2: Placebo Comparator	Drug: Placebo Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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), Cushing178s 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:
1. 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.
2. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566384

Locations


Germany

	Berlin, Germany, 10709

	Berlin, Germany, 13357

	Berlin, Germany, 10627

	Berlin, Germany, 14163

	Berlin, Germany, 14195

Germany, Berlin / 285

	Berlin, Berlin / 285, Germany, 10115

	Berlin, Berlin / 285, Germany, 10247

	Berlin, Berlin / 285, Germany, 13086

	Berlin, Berlin / 285, Germany, 13342

	Berlin, Berlin / 285, Germany, 10629

	Berlin, Berlin / 285, Germany, 10179

	Berlin, Berlin / 285, Germany, 12435

Germany, Hamburg / 287

	Hamburg, Hamburg / 287, Germany, 22143

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91692, 310741, EudraCT No 2006-004397-27
First Received:	November 29, 2007
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00566384
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Institutional Review Board

Keywords provided by Bayer:

Loss of libido

Acquired, oral contraceptive -associated female sexual dysfunction

Study placed in the following topic categories:

Dehydroepiandrosterone

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00566384