Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• A confirmed diagnosis of secondary hypogonadism

• Mild to moderate erectile dysfunction

• Ability to read, understand and complete diaries and questionnaires

• Ability to safely make sexual attempts during the course of the study

Exclusion Criteria:

• Primary hypogonadism

• Hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus or pituitary

• History or current diagnosis of breast cancer, prostate cancer and/or PSA level above ≥3.5 ng/mL

• Poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea

• Elevated prolactin level

• Hemoglobin >17 g/dL or Hematocrit >50%

• Use of transdermal or oral testosterone within 4 weeks, intramuscular testosterone therapy within 6 weeks, and testosterone pellets within 6 months prior to Screening and at any time throughout the study

• Use of another SERM or past participation in a trial with Fispemifene

• Use of medications known to alter the HPG axis

• Clinically significant findings on physical exam, screening labs, or other findings which would prevent safe participation in the study

• Participation in another clinical study in the last 30 days