E4Relief (Response to Estetrol in Life Improvement for MEnopausal-associated Hot Flushes)

What this trial studies

This dose-finding study is being conducted to select the daily oral dose of estetrol (E4) for the treatment of vasomotor symptoms (VMS) in post-menopausal women.

Conditions in scope

• Hot Flushes

Interventions

• Estetrol (Drug) — All treatments (E4 \[2.5 mg, 5 mg, 10 mg, 15 mg\] capsule) will be administered once daily (QD) per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.
• Placebo (Drug) — 1 capsule will be administered QD per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Women presenting at least 7 moderate to severe hot flushes/day or at least 50 moderate to severe hot flushes/week in the week preceding randomization.
• Body Mass Index (BMI) between 18.0 and 35.0 kg/m², inclusive.
• Post-menopausal status.
• Intact uterus.
• Negative pregnancy test.
• Good physical and mental health.
• Subject has provided signed and dated written informed consent before admission to the study.
• Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.

Exclusion criteria

• Uterine disease or any medical conditions associated with an increase in endometrial thickness.
• Any history of malignancy with the exception of basal cell (excluded if within the prior 2 years) or squamous cell (excluded if within the prior one year) carcinoma of the skin. Any clinically significant findings at the breast examination and/or on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer.
• Abnormal cervical Pap smear.
• Systolic blood pressure (BP) outside the range 90 to 140 mmHg, diastolic BP outside the range 60 to 90 mmHg, and/or heart rate outside the range 40 to 100 bpm.
• Any clinically significant abnormality identified on the screening 12-lead ECG.
• History of venous or arterial thromboembolic disease, history of known coagulopathy or abnormal coagulation factors.
• Diabetes mellitus with poor glycaemic control.
• Dyslipoproteinaemia at screening.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2016-05
• Primary completion: 2018-01-22
• Last update posted: 2024-11-18
• First posted: 2016-07-15

Sponsor & contact

Lead sponsor: Donesta Bioscience (Industry)

Collaborators: SynteractHCR

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in weekly frequency of moderate to severe VMS from baseline to week 4. (From baseline to week 4)
• Change in weekly frequency of moderate to severe VMS from baseline to week 12. (From baseline to week 12)
• Change in severity of moderate to severe VMS from baseline to week 4. (From baseline to week 4)
  The Severity Scoring System of VMS will be documented by the subjects by using the following scores: None (0) = No VMS symptoms; Mild (1) = Sensation of heat without sweating; Moderate (2) = Sensation of heat with sweating. Able to continue activity; Severe (3) = Sensation of heat with sweating. Causes cessation of activity.
• Change in severity of moderate to severe VMS from baseline to week 12. (From baseline to week 12)
  The Severity Scoring System of VMS will be documented by the subjects by using the following scores: None (0) = No VMS symptoms; Mild (1) = Sensation of heat without sweating; Moderate (2) = Sensation of heat with sweating. Able to continue activity; Severe (3) = Sensation of heat with sweating. Causes cessation of activity.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.