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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT00283192
Eligibility Criteria:
Inclusion Criteria:
* Age 40 - 60 years old
* Report \> 14 hot flushes per week
* Willing to be randomized to sertraline or placebo
* Sign informed consent
Exclusion Criteria:
* History of bilateral oophorectomy
* Breast or ovarian cancer
* Liver disease
* Kidney disease requiring dialysis
* History of major depression (reported history of depression requiring therapy, hospitalization for depression, taking antidepressant drugs, history of suicide attempt)
* History of bipolar affective disorder (reported history of bipolar disorder requiring therapy, medications, hospitalized for bipolar disorder)
* Seizure disorder
* History of hypersensitivity to sertraline or to SSRIs
* Pregnancy or breast feeding
* Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial;
* No estrogens or progestins for 3 months prior to screening or during enrollment
* Selective estrogen receptor modulators (SERMS)
* The following medications: clonidine, gabapentin, tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitors (SSRIs), megesterol , oral contraceptives, androgens; and medications that are listed on the Pfizer Pharmaceutical drug insert as "contraindicated"
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT00283192
Study Brief:
Protocol Section:
NCT00283192