Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT04516304
Eligibility Criteria:
Inclusion Criteria:
1. Subject is a perimenopausal or menopausal female experiencing specific menopausal-related VMS.
2. Subject has a BMI of ≥18.5 to ≤38.0 kg/m2 at Visit 1 (week -3).
3. At screening visit (Visit 1; week -3), subject reports to have 4 or more moderate to severe hot flushes/night sweats during 24 h prior to the visit. At Visit 3 (week -1), subject has ≥25 moderate to severe hot flushes/night sweats per week for one week between Visit 2 and 3 (weeks -2 and -1). At Visit 4 (week 0), subject has an average ≥28 moderate to severe hot flushes/night sweats per week for 2 weeks before Visit 4 (week 0).
4. Subject is willing to maintain habitual diet (with the exception of restricted foods/beverages), physical activity patterns, and body weight during the study period.
5. Subject is willing to abstain from using products (other than study product) that contains estrogen, progestin, or progesterone within 30 d prior to Visit 1 (week -3) and throughout the study trial.
6. If a smoker, subject is willing to maintain current smoking habits.
7. Subject has no health conditions that would prevent her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
8. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Exclusion Criteria:
1. Subject has abnormal laboratory test results of clinical importance at Visit 1 (week -3) at the discretion of the Investigator.
2. Subject has a history or presence of clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions), neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders, that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
3. Subject has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
4. Subject has a history of estrogen-dependent neoplasia, atypical ductual hyperplasia of the breast, or undiagnosed vaginal bleeding.
5. Subject has a history of endometrial hyperplasia, melanoma, or uterine/endometrial breast or ovarian cancer.
6. Subject has uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (week -3). One re-test will be allowed on a separate day for subjects whose blood pressure exceeds either of these cut points at Visit 1, in the judgment of the Clinical Investigator.
7. Subject has a history of any major trauma or major surgical event within two months of Visit 1 (week -3).
8. Subject has a history or presence of cancer in the prior 2 years to Visit 1 (week -3), except for non-melanoma skin cancer.
9. Subject has a contraindication to estrogen and/or progestin therapy or allergy/sensitivity to the use of estradiol and/or progesterone, soy, or any components in the study product.
10. Subject has used estrogen alone or estrogen/progestin, selective estrogen receptor modulator, testosterone, or estrogen/testosterone within 30 d prior to Visit 1 (week -3).
11. Subject has used any prescription or over-the-counter products/supplements (e.g., soy products, herbal supplements) that have potential to alter progesterone or estrogen activity or is being used to treat VMS within 30 d prior to Visit 1 (week -3).
12. Subject has self-described extreme or irregular dietary habits, in the opinion of the Clinical Investigator or has been diagnosed with an eating disorder.
13. Subject has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
14. Subject has been exposed to any non-registered drug product or has participated in another intervention study within 30 d prior to Visit 1 (week -3).
15. Subject has a recent history of (within 12 months of screening; Visit 1; week -3) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
16. Individual has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT04516304
Study Brief:
Protocol Section:
NCT04516304