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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03700658
Eligibility Criteria:
Inclusion Criteria:
* Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device \[IUD\], or consistent use of condoms)
* Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
* Participant had a normal mammogram within the last year, if 40 years or older
* Participant has no skin disorders or skin allergies
* Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
* Participant has hypertension
* Participant has ischemic heart disease or a history of ischemic heart disease
* Participant has a history of stroke
* Participant has a history of thromboembolic event(s)
* Participant has systemic lupus erythematosus
* Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
* Participant has migraine with aura
* Participant has unexplained vaginal bleeding
* Participant has diabetes
* Participant has a strong family history of breast cancer
* Participant has cervical cancer or a history of cervical cancer
* Participant has severe cirrhosis (decompensated) or liver tumors
* Participant has known significant renal disease
* Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
* Participant is currently using hormonal contraception
* Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
* Participant is chronically using pain medication
* Participant has a plan to move to another location in the next 18 months
* Additional criteria apply, please contact the investigator for more information
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03700658
Study Brief:
Protocol Section:
NCT03700658