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 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT01254292
Eligibility Criteria:
Inclusion Criteria:
* Subject has signed and dated the Informed Consent Form (ICF).
* The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.
* In the opinion of the investigator, the subject is
* in good health;
* without uterine conditions that would preempt insertion of LCS12;
* without conditions/history that would contraindicate the use of oral contraceptives.
* Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.
* As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).
* Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.
Exclusion Criteria:
* Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.
* Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)
* Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.
* Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding
* Any genital infection (until successfully treated)
* Abnormal cervical smear result (see inclusion criteria)
* Acute, current or history of recurrent pelvic inflammatory disease
* Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
29 Years
Study:
NCT01254292
Study Brief:
Protocol Section:
NCT01254292