LCS16 vs. COC User Satisfaction and Tolerability Study

Bayer

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: Levonorgestrel (Kyleena, BAY86-5028)

Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03074045

17878

Details and patient eligibility

About

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.

Enrollment

145 patients

Sex

Female

Ages

18 to 29 years old

Volunteers

No Healthy Volunteers

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.