LCS16 vs. COC User Satisfaction and Tolerability Study

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Drospirenone; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Levonorgestrel; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• The subject has signed and dated the Informed Consent Form (ICF).

• The subject is healthy when requesting contraception.

• The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF.

• The subject has normal or clinically insignificant cervical smear for oncocytology (i.e. Pap test) not requiring further follow up (a cervical smear has to be taken at the Screening Visit [Visit 1] or a normal result has to have been documented within the previous 6 months).

• The subject has a history of regular (i.e., endogenous cyclicity without hormonal contraceptive use) cyclic menstrual periods (length of cycle 21 - 35 days), as confirmed by the subject.

• The 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 postpartum or since abortion before the Screening Visit)

• Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit.

• Chronic, daily use of drugs that may increase serum potassium levels.

• Undiagnosed abnormal genital bleeding.

• Acute cervicitis or vaginitis (until successfully treated).

• Lower urinary tract infection (until successfully treated).

• Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections.

• Congenital or acquired uterine anomaly including fibroids, in the opinion of the investigator, which would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity).

• Cervical neoplasia, uterine or cervical malignancy, or sex hormone-dependent tumors.

• History of migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.