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:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00560833
Eligibility Criteria:
Inclusion Criteria:
* postmenopausal women, defined as:
* 12 months of spontaneous amenorrhea;
* OR 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone
(FSH) levels \>40 mIU/mL;
* OR 6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
* In case the menopausal status of a subject was unclear because of a hysterectomy, the serum FSH level had to be \>40 mIU/mL. If the date of the last menstruation was not clear because of perimenopausal hormone use, then the subject had to have a serum FSH level \>40 mIU/mL after completion of a washout period (see exclusion criteria below); be \>= 40 and \<= 65 years of age;
* have a body mass index (BMI) \>= 18 and \<= 32 kg/m\^2;
* minimum of 7 moderate to severe hot flushes per day or 50 per week, as quantified from daily diary recordings during at least 7 days preceding randomization to trial medication;
* able to handle the electronic diary device after training and having at least 80% compliance on complete daily diary entries during the period prior to randomization;
* give voluntary written Informed Consent (IC) after the scope and nature of the investigation had been explained, before screening evaluations.
Exclusion Criteria:
* history or presence of any malignancy, except non-melanoma skin cancers
* any clinically unstable or uncontrolled renal, hepatic, endocrine,
respiratory, hematological, neurological, cardiovascular, or cerebrovascular disease that would put the subject at safety risk or mask measure of efficacy
* history of seizures or epilepsy; history or presence of clinically significant depression or other psychiatric disorder which, in the opinion of the investigator, might compromise or confound the participant's participation in the trial; abnormal clinically relevant vaginal bleeding
* any clinically relevant (opinion of investigator) abnormal finding during physical, gynecological and breast examination at screening; abnormal, clinically significant results of mammography. Mammography had to have been performed within the last 9 months prior to screening, otherwise it had to be done before inclusion into the trial. For non-US sites, if local laws or guidelines did not allow or advise such frequent mammograms, the documented local laws or guidelines were to be followed; abnormal cervical smear test results (corresponding to Pap III and higher, including Low-Grade Squamous Intraepithelial Lesion (LSIL), High-Grade Squamous Intraepithelial Lesion (HSIL), Cervical Intraepithelial Neoplasia (CIN) 1 and higher). A cervical smear had to have been performed within the last 9 months prior to screening, otherwise it had to be done before inclusion into the trial; hematological or biochemical values at screening outside the reference ranges considered clinically relevant in the opinion of the investigator
* high blood pressure (BP) (sitting systolic BP \>170 mmHg and/or diastolic BP \>100 mmHg)
* use of any drug product containing estrogens, progestins, androgens, or tibolone prior to screening (and up to and including randomization) within specified time frames
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT00560833
Study Brief:
Protocol Section:
NCT00560833