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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02443090

Enrollment

160

Registered

2015-05-13

Start date

2015-05-31

Completion date

2016-04-30

Last updated

2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Secondary Hypogonadism, Sexual Dysfunction

Keywords

secondary hypogonadism, sexual dysfunction, erectile dysfunction

Brief summary

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

Detailed 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.

Interventions

DRUGfispemifene

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026