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

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

Detailed Description
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This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week run-in and an 8-week treatment period. It will assess the safety and tolerability of fispemifene, and the effects of treatment on the sexual side effects seen in this patient population using PRO endpoints.

Official Title
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An 8-Week Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

Conditions
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Secondary Hypogonadism, Sexual Dysfunction, Erectile Dysfunction

Intervention / Treatment
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* Drug: fispemifene
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fispemifene 450 mg<br>Fispemifene capsules will be taken orally each morning immediately after eating a meal | Drug: fispemifene<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules will be taken orally each morning immediately after eating a meal | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IIEF-EF (International Index of Erectile Function - erectile function domain) score | Change in the IIEF-EF (International Index of Erectile Function - erectile function domain) score from Randomization to Week 8 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary hypogonadism, sexual dysfunction, erectile dysfunction