HSDD Hypoactive Sexual Desire Disorder
Conditions
Interventions
Medical and sexuological history, bloodpressure and pulse, length and weight,
physical exam, blood drawing, urine pregnancytest, PET scan, questionnaires,
medication intake.
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have a primary diagnosis of HSDD, generalized acquired type, according to DSM IV-TR criteria. The current episode of HSDD must be at least 24 weeks in duration at the time of the Screening Visit. Patients with secondary Female Sexual Arousal Disorder and / or Female Orgasmic Disorder are allowed in the trial provided that the patient considers HSDD to be of greatest importance. 2. Patients must be female and 18 years of age or older at the Screen visit. 3. Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. 4. Pre-menopausal women per the Stages of Reproductive Aging Workshop (STRAW) criteria 5. Patients must be currently using hormonal contraceptive therapy (subcutaneous, injectable, intra-vaginal or oral contraceptive) for at least 3 months before the Screening Visit and continue to use the method of contraception during the trial. However, if the use of a contraceptive is judged to be a contributing factor to the patient's HSDD, the patient should be excluded from the trial. 6. Patients must be able and willing to give meaningful, written informed consent consistent with International Conference on Harmonisation (ICH) / Good Clinical Practice (GCP) guidelines and local regulations prior to participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition. 2. Patients who have entered the peri-menopause stage (menopausal transition) or the post menopause stage according to the STRAW criteria 3. Patients with findings at the Screening Visit of pelvic pain, pelvic inflammatory disease, endometriosis, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. 4. Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline visit. 5. Patients with a history of any other psychiatric disorders that could impact sexual function, risks patient's safety, or may impact compliance. 6. Patients who have been subject to procedures involving ionizing radiation during the last two years prior to the Screening Visit. 7. Patients who are left-handed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in regional cerebral blood flow in response to various visual stimuli ascertained by Positron Emission Tomography scan after 8 weeks of flibanserin 100 mg treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| none | — |
Countries
Netherlands
Outcome results
None listed