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

NCT00566384 | Completed Phase 2

• 3 other identifiers: 916923107412006-004397-27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

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

Keywords

Loss of libido; Acquired, oral contraceptive -associated female sexual dysfunction

Outcome Measures

Primary Outcomes (1)

• FSDS questionnaire (sexual desire and arousal component scores)

  at baseline and after Cycle 6

Secondary Outcomes (7)

• Change from baseline period to cycle 6 in the number of satisfactory sexual events

  after Cycle 6

• FSFI questionnaire (absolute values and change from baseline) - All domains

  Cycle 1, 3, 6 and follow-up

• FSDS-R questionnaire results

  Cycle 1, 3, 6 and follow-up

• FSEP questionnaire results

  Cycle 1, 3, 6 and follow-up

• PGWBI questionnaire results

  Cycle 1, 3, 6 and follow-up

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: Dehydroepiandrosterone, BAY86-5314

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dehydroepiandrosterone, BAY86-5314 DRUG

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

Arm 1

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (11)

Unknown Facility

Hamburg, Hamburg, 22143, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10247, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10627, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10629, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10709, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12435, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13086, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13357, Germany

Location

Unknown Facility

Berlin, State of Berlin, 14195, Germany

Location

Related Links

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MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

DE (11)