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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00566384
First received: November 29, 2007
Last updated: May 19, 2014
Last verified: May 2014
  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, BAY86-5314
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 100
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Dehydroepiandrosterone, BAY86-5314
Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
Placebo Comparator: Arm 2 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), 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Berlin, Germany, 13357
Berlin, Germany, 13086
Berlin, Germany, 13353
Berlin, Germany, 10627
Berlin, Germany, 12435
Berlin, Germany, 10115
Berlin, Germany, 10247
Berlin, Germany, 10709
Berlin, Germany, 10629
Berlin, Germany, 14195
Hamburg, Germany, 22143
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00566384     History of Changes
Other Study ID Numbers: 91692, 310741, 2006-004397-27
Study First Received: November 29, 2007
Last Updated: May 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Loss of libido
Acquired, oral contraceptive -associated female sexual dysfunction

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Dehydroepiandrosterone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 31, 2014