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.
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
none
Background summary
The prevalence of HSDD worldwide is about 10-20%. The aetiology is unknown:
there are no clear psychological or physical causes.
Study objective
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.
Study design
De study is being performed in the UMCG in cooperation with Boehringer
Ingelheim BV (sponsor). The Center for Uroneurology and the departments of
Gynaecology and Nucleair Medicine are involved. The study starts February 2010
and ends May 2011.
In total 26 women with HSDD will participate:
13 women will be treated for 8 weeks with flibanserin. The other 13 will
receive placebo. The study is randomised and doubleblind.
At Visit 1 in- and exclusioncriteria are determined. At visit 2 patients will
have their first PET scan. During the PET scan the patients will watch neutral
or erotic film fragments. The night of visit 2 patient begin treatment with
studymedication. This will continue for 8 weeks. Visit 3 and 4 are safety
visits. At visit 5, after 8 weeks of flibanserin use, the second PET scan takes
place. Visit 6 is another safety visit.
Intervention
Medical and sexuological history, bloodpressure and pulse, length and weight,
physical exam, blood drawing, urine pregnancytest, PET scan, questionnaires,
medication intake.
Study burden and risks
The patients are under medical supervision of kwalilfied staff. Flibanserin has
been used by over 7300 people and side effects so far are mild to moderate. The
radiation exposure is about twice the background radiation and comparable to
medical diagnostic procedures.
Comeniusstraat 6
1817 MS ALKMAAR
Nederland
Comeniusstraat 6
1817 MS ALKMAAR
Nederland
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-016202-16-NL |
| CCMO | NL30623.042.09 |