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 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
NCT ID:
NCT02141061
Eligibility Criteria:
Inclusion Criteria:
1. Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
2. Healthy, premenopausal female age 18-47;
3. History of menstrual events that occur in regular cycles
4. Agreement not to attempt to become pregnant
5. Agrees to use double-barrier contraception during the study and for 30 days after discontinuation of study medication. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide;
6. Has a negative pregnancy test at the Screening visit. An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
7. Normal laboratory values or clinically insignificant findings at screening as determined by the Investigator;
8. Subject is willing to remain in the clinic overnight for PK assessment on Days 0 and 8
9. Ability to complete the study procedures in compliance with the protocol.
Exclusion Criteria:
1. Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
2. Subject is pregnant or lactating or is attempting or expecting to become pregnant during the study
3. Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 2.0 x ULN AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat).
4. Received an investigational drug in the 30 days prior to the screening for this study
5. Women with a history of PCOS
6. Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
7. Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 10 months.
8. Has an IUD in place
9. Women currently using narcotics
10. Women currently taking spironolactone
11. Infectious disease screen is positive for HIV or Hepatitis A, B or C.
12. Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
47 Years
Study:
NCT02141061
Study Brief:
Protocol Section:
NCT02141061