Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Sprout Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Sexual Dysfunctions, Psychological

Treatments: Drug: Flibanserin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996164

511.147

Details and patient eligibility

About

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

Enrollment: 1,090 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Premenopausal women who are 18 years old and older
2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
3. Stable, monogamous heterosexual relationship for at least one year.
4. Willing to discuss sexual issues.
5. Willing to engage in sexual activity at least once a month
6. Normal pap smear
7. Must use medically acceptable method of contraception
8. Able to comply with daily use of a handheld entry device

Exclusion criteria

1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
3. Partner with inadequately treated organic or psychosexual dysfunction
4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
5. Sexual function impaired by psychiatric disorder
6. Sexual function impaired by gynecological disorder
7. Major life stress that could impair sexual function
8. Substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,090 participants in 2 patient groups, including a placebo group

flibanserin 100 mg

Experimental group

Description:

flibanserin 100mg po qd

Treatment:

Drug: Flibanserin

Placebo

Placebo Comparator group

Description:

placebo 1 tab po qd

Treatment:

Drug: Placebo