CompletedPhase 3

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

United States1,570 participantsStarted 2019-12-30

Plain-language 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)

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. For the Efficacy Study part: at least 7 moderate to severe bothersome VMS per day or at least 50 moderate to severe bothersome VMS per week in the last 7 consecutive days during the Screening period;
✓. For the Endometrial and General Safety Study part: at least 1 moderate to severe VMS per week;

Exclusion criteria

✕. or at least 6 months of spontaneous amenorrhea with serum FSH \>40 mIU/mL and E2 \<20 pg/mL (\<73.4 pmol/L,value obtained after washout of estrogen/progestin containing drugs, see exclusion criteria 18 and 20);
✕. or at least 6 weeks postsurgical bilateral oophorectomy;
✕. serum FSH \>40 mIU/mL and E2 \<20 pg/mL (\<73.4 pmol/L, values obtained after washout of estrogen/progestin containing drug see exclusion criteria 18 and 20);
✕. or at least 6 weeks post-surgical bilateral oophorectomy.
✕. History or presence of uterine cancer, endometrial hyperplasia, or disordered proliferative endometrium;
✕. Presence of endometrial polyps;
✕. Undiagnosed vaginal bleeding or undiagnosed abnormal uterine bleeding;
✕. Endometrial ablation;

What they're measuring

Mean change in weekly frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy Study Part)

Timeframe: Baseline and Week 4

Mean change in weekly frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy Study Part)

Timeframe: Baseline and Week 12

Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy Study Part)

Timeframe: Baseline and Week 4

Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy Study Part)

Timeframe: Baseline and Week 12

Incidence of endometrial hyperplasia with up to 12 months of treatment based on endometrial biopsies (Endometrial and General Safety Study Part)

Timeframe: Screening and Week 53

Trial details

NCT IDNCT04209543

SponsorEstetra

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-08

View on ClinicalTrials.gov More Vasomotor Symptoms trials

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. For the Efficacy Study part: at least 7 moderate to severe bothersome VMS per day or at least 50 moderate to severe bothersome VMS per week in the last 7 consecutive days during the Screening period;
✓. For the Endometrial and General Safety Study part: at least 1 moderate to severe VMS per week;

Exclusion criteria

✕. or at least 6 months of spontaneous amenorrhea with serum FSH \>40 mIU/mL and E2 \<20 pg/mL (\<73.4 pmol/L,value obtained after washout of estrogen/progestin containing drugs, see exclusion criteria 18 and 20);
✕. or at least 6 weeks postsurgical bilateral oophorectomy;
✕. serum FSH \>40 mIU/mL and E2 \<20 pg/mL (\<73.4 pmol/L, values obtained after washout of estrogen/progestin containing drug see exclusion criteria 18 and 20);
✕. or at least 6 weeks post-surgical bilateral oophorectomy.
✕. History or presence of uterine cancer, endometrial hyperplasia, or disordered proliferative endometrium;
✕. Presence of endometrial polyps;
✕. Undiagnosed vaginal bleeding or undiagnosed abnormal uterine bleeding;
✕. Endometrial ablation;

What they're measuring

Mean change in weekly frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy Study Part)

Timeframe: Baseline and Week 4

Mean change in weekly frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy Study Part)

Timeframe: Baseline and Week 12

Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy Study Part)

Timeframe: Baseline and Week 4

Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy Study Part)

Timeframe: Baseline and Week 12

Incidence of endometrial hyperplasia with up to 12 months of treatment based on endometrial biopsies (Endometrial and General Safety Study Part)

Timeframe: Screening and Week 53