Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

ClinicalTrials.gov ID: NCT04209543
Sponsor: Estetra
Information provided by: Estetra (Responsible Party)
Last Update Posted: 2023-12-11

Brief Summary:
This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Endometrial and General Safety Study Part)

Detailed Description:
This is a two-part study:
- The Efficacy Study Part is designed to evaluate the frequency and severity of vasomotor symptoms [VMS] in both hysterectomized and non-hysterectomized postmenopausal participants after treatment with E4 15 mg or 20 mg or placebo for up to 13 consecutive weeks. For endometrial protection, all non-hysterectomized participants will be treated with 200 mg progesterone (P4) once daily for 14 consecutive days, after completion of the E4/placebo treatment.
- The Endometrial and General Safety Study Part (Safety Part) is designed to evaluate the general safety, endometrial safety, secondary efficacy (lipid, glucose metabolism, health-related quality of life [HRQoL] and treatment satisfaction) of E4 in non-hysterectomized participants. All participants will receive E4 20 mg in combination with 100 mg P4 continuously for up to 53 weeks.

Official Title:
A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

Intervention / Treatment:
- Drug: Estetrol oral tablet
- Drug: Placebo oral tablet
- Drug: Progesterone oral tablet

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