Efficacy and Safety of Fispemifene in the Treatment of Hypogonadal Men With Chronic Obstructive Pulmonary Disease That Are on Oral Glucocorticoid Therapy: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study

NCT01061970 Phase 2 COMPLETED

The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 4 weeks in the treatment of hypogonadal men with chronic obstructive pulmonary disease (COPD) that are on oral glucocorticoid therapy.

Details

Lead sponsor	QuatRx Pharmaceuticals Company
Phase	Phase 2
Status	COMPLETED
Enrolment	15
Start date	2007-01
Completion	2007-10

Conditions

• Hypogonadism
• Chronic Obstructive Pulmonary Disease

Interventions

• Fispemifene

Primary outcomes

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