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

NexMed

Status and phase: Unknown; Phase 2

Conditions: Erectile Dysfunction; Sexual Dysfunction; Secondary Hypogonadism

Treatments: Drug: fispemifene; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02443090

NM-F15-202

Details and patient eligibility

About

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

Full description

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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

160 participants in 2 patient groups, including a placebo group

Fispemifene 450 mg

Experimental group

Description:

Fispemifene capsules will be taken orally each morning immediately after eating a meal

Treatment:

Drug: fispemifene

Placebo

Placebo Comparator group

Description:

Placebo capsules will be taken orally each morning immediately after eating a meal

Treatment:

Other: Placebo