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Safety Extension of Leflutrozole in Hypogonadotropic Hypogonadism
NCT02908074Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2016
- Primary completion
- Sep 2018
- Countries
- 1
- Sponsor
- Mereo BioPharma
- Modality
- Small Molecules
- Drugs
- leflutrozole
- Conditions
- hypogonadotropic hypogonadism (HH)
01
Overview
Phase 2, randomised, double-blind trial of leflutrozole in hypogonadotropic hypogonadism (HH) (3 arms), sponsored by Mereo BioPharma. Primary endpoint: Percent Change in Bone Mineral Density Measured by DEXA at 48 weeks. Started Nov 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
BGS649 0.1 mg
Leflutrozole 0.1 mg weekly
BGS649 0.3 mg
Leflutrozole 0.3 mg weekly
BGS649 1.0 mg
Leflutrozole 1.0 mg weekly
03
Endpoints
Primary
Percent Change in Bone Mineral Density Measured by DEXA
Secondary
Percentage Change From Baseline in DEXA Scan Density by Location
Descriptive Summary of Percentage Change in Bone Turnover Markers
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location
Change From Baseline of Oestradiol
Analysis of Proportion of Subjects That Overshoot Testosterone
Change From Baseline in PSA
Change From Baseline in Haematocrit
Change From Baseline in Blood Pressure
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