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Completed

NCT Number: NCT00277914

Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

Completed

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Key information

Conditions

Sexual Dysfunctions, Psychological Mental Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

511.74.02011 Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women over 18 and pre-menopausal
  • FSDS-R above 14
  • Willingness to try to have sexual activity at least monthly
  • Willingness to use an electronic diary daily
  • Stable, monogamous, heterosexual relationship for at least one year
  • Medically acceptable method of contraception

Exclusion criteria

  • Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
  • Specified medications
  • Sexual function affected by medication
  • Drug dependence or abuse
  • Sexual partner needing treatment
  • Peri-Menopause or Menopause (surgical or otherwise)
  • Pregnancy
  • Pelvic Inflammatory Disease
  • Major depressive Episode
  • Significant ECG abnormalities
  • Significant Neurologic findings
  • Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
  • Uncorrected thyroid or endocrine disease
  • Uncontrolled Glaucoma

Treatment and study plan

flibanserin

Drug

flibanserin flexible dosing

Primary outcomes

  1. Duration of efficacy of flibanserin in Sexually Satisfying Events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sprout Pharmaceuticals, Inc

Industry

Registry information

Official study title

12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 18, 2006
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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