LCS16 vs. COC User Satisfaction and Tolerability Study

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03074045

Collaborator

(none)

145

Enrollment

Locations

Arms

64.8

Actual Duration (Months)

16.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Levonorgestrel (Kyleena, BAY86-5028) Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multi-center, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 16 μg LNG/Day Initial in Vitro Release Rate (LCS16) in Comparison to a Combined Oral Contraceptive (COC) Containing 30 μg Ethinyl Estradiol and 3 mg Drospirenone (Yarina®) in Young Nulliparous and Parous Women (18 - 29 Years) Over 12 Months of Use (With an Option for Extended Use of LCS16 for up to 5 Years)

Actual Study Start Date :

Mar 13, 2017

Actual Primary Completion Date :

Sep 3, 2018

Actual Study Completion Date :

Aug 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test LCS16 (Low-dose LNG IUS)	Drug: 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
Active Comparator: Reference COC (Yarina)	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

Arm

Intervention/Treatment

Experimental: Test

LCS16 (Low-dose LNG IUS)

Drug: 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

Active Comparator: Reference

COC (Yarina)

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

Outcome Measures

Primary Outcome Measures

Overall satisfaction rate [12 months]
5-point Likert item Very satisfied Satisfied Neither satisfied nor dissatisfied Dissatisfied Very dissatisfied

Secondary Outcome Measures

Number of adverse events [Up to 5 years]
at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.
Discontinuation rates [Up to 5 years]
at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.
Bleeding pattern [Up to 12 months]
Only during the comparative part of the study
User satisfaction and bleeding questionnaire [Up to 12 months]
At 6 and 12 months after the start of study treatment (or at early termination for those subjects discontinuing the study before completion of the 12 months) for all subjects during the comparative part of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 29 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Altai State Medical University	Barnaul	Russian Federation	656038
2	Scientific Center of family health & human reprod. problems	Irkutsk	Russian Federation	664003
3	Krasnoyarsk State Medical University	Krasnoyarsk	Russian Federation	660022
4	City Clinical Hospital #13 Moscow	Moscow	Russian Federation	115280
5	LLC Reafan	Novosibirsk	Russian Federation	630099
6	Medical Center "Avicenna"	Novosibirsk	Russian Federation	630099
7	Smolensk State Medical University	Smolensk	Russian Federation	214019
8	LLC Medical center PRIME ROSE	St. Petersburg	Russian Federation	197374
9	Regional perinatal center	Yaroslavl	Russian Federation	150042