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

• Status: Completed
• Trial end date: 2018-01-22
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Donesta Bioscience
• Collaborators: Chiltern International Inc.; SynteractHCR

Criteria

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.

• Smoking >10 cigarettes/day.

• Presence or history of gallbladder disease, unless cholecystectomy has been performed.

• Systemic lupus erythematosus.

• Multiple sclerosis.

• Acute or chronic liver disease.

• Acute or chronic renal impairment.

• Uncontrolled thyroid disorders.

• Use of oestrogen or progestin containing drug(s).

• Use of non-hormonal treatments to reduce hot flushes.

• History or presence of allergy or intolerance to any component of the investigational product.

• History of alcohol or substance abuse or dependence in the 12 months before screening as determined by the Investigator.

• Sponsor, CRO or Investigator's site personnel or their relatives directly affiliated with this study.

• Subjects with known or suspected history of a clinically significant systemic diseases, unstable medical disorders, life-threatening disease or current malignancies that would pose a risk to the subject in the opinion of the Investigator.

• Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to study entry.

• Is judged by the Investigator to be unsuitable for any reason.