A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE INFLUENCE OF ESTETROL (E4) ON HAIR GROWTH PARAMETERS IN POSTMENOPAUSAL WOMEN WITH FEMALE PATTERN HAIR LOSS (PILOT STUDY)

Conditions

postmenopausal women with vasomotor menopausal symptoms

Brief summary

Change from baseline in TAHC (non-vellus) and TAHW (non-vellus and vellus/vellus like hair) at Week 22 vs placebo; Safety endpoints: Frequency of TE(S)AEs; Categorical changes in physical, TVUS, vital signs, breast exam, and lab results at each time point; Change from baseline in endometrial thickness ; Proportion of women with vaginal bleeding/spotting per 28-day treatment cycle with E4 20 mg or placebo; Proportion of women with amenorrhea per 28-day treatment cycle with E4 20 mg or placebo

Detailed description

Change from baseline: in TAHC (non-vellus) at Week 10 vs placebo; in TAHC (vellus/vellus like hair) at Weeks 10 and 22 vs placebo; in TAHW (non-vellus) at Week 10 vs placebo; in TAHW (vellus/vellus like hair) at Weeks 10 and 22 vs placebo; HGA score at Weeks 10 and 22 vs placebo; HGI at Weeks 10 and 22 vs placebo; HGSS score at Weeks 10 and 22 vs placebo; IGA of scalp hair growth at Weeks 10 and 22; Change from baseline in WAA-QoL total score at Week 22 vs placebo

Related papers

No related papers found yet.

Interventions

DRUGFilm-coated placebo to match estetrol monohydrate (E4) 20mg tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in TAHC (non-vellus) and TAHW (non-vellus and vellus/vellus like hair) at Week 22 vs placebo; Safety endpoints: Frequency of TE(S)AEs; Categorical changes in physical, TVUS, vital signs, breast exam, and lab results at each time point; Change from baseline in endometrial thickness ; Proportion of women with vaginal bleeding/spotting per 28-day treatment cycle with E4 20 mg or placebo; Proportion of women with amenorrhea per 28-day treatment cycle with E4 20 mg or placebo	—

Measure

Time frame