Trial Condition(s):

Libido

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

Bayer Identifier:

91692

ClinicalTrials.gov Identifier:

NCT00566384

EudraCT Number:

2006-004397-27

Study Completed

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.

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

Trial Summary

Enrollment Goal
100
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Dehydroepiandrosterone - DHEA (BAY86-5314)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Fr. Dr. Kirsten Kuhlmann

Berlin, Germany, 13357

Status
Completed
 
Locations

Praxis Hr. Dr. Karl-Heinz Belling

Berlin, Germany, 13086

Status
Completed
 
Locations

Bayer Pharma AG

Berlin, Germany, 13353

Status
Completed
 
Locations

Praxis Fr. Dr. Claudia Ehle

Berlin, Germany, 10627

Status
Completed
 
Locations

CRH Clinical Research Hamburg GmbH

Hamburg, Germany, 22143

Status
Completed
 
Locations

Praxis Fr. Dr. M. Weber u. Fr. Dr. vn der Gablentz

Berlin, Germany, 12435

Status
Completed
 
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Completed
 
Locations

Frauenarztpraxis Hr. Dr. H. Lindecke

Berlin, Germany, 10247

Status
Completed
 
Locations

Praxis Fr. Dr. Ursula Weingarten

Berlin, Germany, 10709

Status
Completed
 
Locations

emovis GmbH

Berlin, Germany, 10629

Status
Completed
 
Locations

Gemeinschaftspraxis Dr. R. Willroth & Dr. A. Novak

Berlin, Germany, 14195

Status
Completed
 

Trial Design