LCS16 vs. COC User Satisfaction and Tolerability Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2022-08-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test

LCS16 (Low-dose LNG IUS)

Group Type EXPERIMENTAL

Levonorgestrel (Kyleena, BAY86-5028)

Intervention Type DRUG

Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years

Reference

COC (Yarina)

Group Type ACTIVE_COMPARATOR

Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

Intervention Type DRUG

COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months

Interventions

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Levonorgestrel (Kyleena, BAY86-5028)

Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years

Intervention Type DRUG

Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No