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A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism

Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00290134
Enrollment
100
Registered
2006-02-10
Start date
2006-02-28
Completion date
2007-10-31
Last updated
2008-03-03

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

Conditions

Hypogonadism

Keywords

Hypogonadism, Testosterone

Brief summary

The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.

Interventions

DRUGFispemifene once daily for 4 weeks

Sponsors

Hormos Medical
CollaboratorINDUSTRY
QuatRx Pharmaceuticals Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Total testosterone level \<240 ng/dL * Serum LH and FSH levels within normal limits

Exclusion criteria

* Elevated prolactin * Evidence of Benign Prostatic Hypertrophy * History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy * Clinically significant endocrine/metabolic or cardiovascular disease * Significant polycythemia

Design outcomes

Primary

MeasureTime frame
Change in morning total testosterone levels from baseline to Week 4 (end of therapy)—

Secondary

MeasureTime frame
Change in total testosterone levels from baseline to Weeks 2 and 6—
Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6—
Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6—

Countries

United States

Outcome results

None listed

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