check_circleStudy Completed

Libido

Efficacy and safety of oral dehydroepiandrosterone as a concomitant therapy to oral contraceptives in women complaining of reduced libido

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
100
Trial Dates
November 2007 - April 2009
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Dehydroepiandrosterone - DHEA (BAY86-5314)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Fr. Dr. Kirsten KuhlmannBerlin, 13357, Germany
Completed
Praxis Hr. Dr. Karl-Heinz BellingBerlin, 13086, Germany
Completed
Bayer Pharma AGBerlin, 13353, Germany
Completed
Praxis Fr. Dr. Claudia EhleBerlin, 10627, Germany
Completed
CRH Clinical Research Hamburg GmbHHamburg, 22143, Germany
Completed
Praxis Fr. Dr. M. Weber u. Fr. Dr. vn der GablentzBerlin, 12435, Germany
Completed
Dinox GmbH BerlinBerlin, 10115, Germany
Completed
Frauenarztpraxis Hr. Dr. H. LindeckeBerlin, 10247, Germany
Completed
Praxis Fr. Dr. Ursula WeingartenBerlin, 10709, Germany
Completed
emovis GmbHBerlin, 10629, Germany
Completed
Gemeinschaftspraxis Dr. R. Willroth & Dr. A. NovakBerlin, 14195, Germany

Primary Outcome

  • FSDS questionnaire (sexual desire and arousal component scores)
    date_rangeTime Frame:
    at baseline and after Cycle 6
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change from baseline period to cycle 6 in the number of satisfactory sexual events
    date_rangeTime Frame:
    after Cycle 6
    enhanced_encryption
    Safety Issue:
    no
  • FSFI questionnaire (absolute values and change from baseline) - All domains
    date_rangeTime Frame:
    Cycle 1, 3, 6 and follow-up
    enhanced_encryption
    Safety Issue:
    no
  • FSDS-R questionnaire results
    date_rangeTime Frame:
    Cycle 1, 3, 6 and follow-up
    enhanced_encryption
    Safety Issue:
    no
  • FSEP questionnaire results
    date_rangeTime Frame:
    Cycle 1, 3, 6 and follow-up
    enhanced_encryption
    Safety Issue:
    no
  • PGWBI questionnaire results
    date_rangeTime Frame:
    Cycle 1, 3, 6 and follow-up
    enhanced_encryption
    Safety Issue:
    no
  • Serum hormone levels (SHBG, T, DHEA, DHEA-S)
    date_rangeTime Frame:
    Cycle 1, 3, 6 and follow-up
    enhanced_encryption
    Safety Issue:
    no
  • Vaginal pH
    date_rangeTime Frame:
    Cycle 1, 3, 6 and follow-up
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2