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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT05959057
Eligibility Criteria:
Inclusion Criteria:
* Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive
* Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.
Exclusion Criteria:
* A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
* History of Breast or Uterine cancers.
* Known infection with HIV, Tuberculosis or Hepatitis B or C.
* Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)
* Hormonal Contraceptives: All formulations of synthetic estrogens and progestins
* Botanical Formulations - including phytoestrogens and progesterone-mimetic botanicals (Rhapontic Rhubarb, Soy Phytoestrogens, Hops (8-prenyl naringin) Red Clover, Kudzu, Chaste Tree Berry, Licorice, Resveratrol, Black Cohosh, Dong Quai, etc.)
* Use of Narcotics during the last 30 days
* Use of Anticoagulants during last 30 days
* Use of Corticosteroids during the last 30 days
* Use of controlled substances (other than marijuana or CBD) on a recreational basis during the last 30 days.
* Consumption of more than 3 alcoholic beverages per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
* Pregnancy
* Breast Feeding
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
64 Years
Study:
NCT05959057
Study Brief:
Protocol Section:
NCT05959057