Study Completed

Contraception

Bayer Identifier:

17878

ClinicalTrials.gov Identifier:

NCT03074045

EudraCT Number:

Not Available

EU CT Number:

Not Available

LCS16 vs. COC user satisfaction and tolerability study

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 29 Years

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.

Trial summary

Enrollment Goal

145

Trial Dates

March 2017 - August 2022

Phase

Phase 3

Could I Receive a placebo

Products

Kyleena (Levonorgestrel, BAY86-5028)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn	Scien. Res. Institute of Obsterics, Gyn. & Reproduction	St. Petersburg, 199034, Russian Federation
Completed	City Clinical Hospital #13 Moscow	Moscow, 115280, Russian Federation
Withdrawn	Moscow Regional Sc. Res. Institue of Obstetrics & Gynecology	Moscow, 101000, Russian Federation
Completed	Smolensk State Medical University	Smolensk, 214019, Russian Federation
Completed	Altai State Medical University	Barnaul, 656038, Russian Federation
Completed	Scientific Center of family health & human reprod. problems	Irkutsk, 664003, Russian Federation
Completed	LLC Medical center PRIME ROSE	St. Petersburg, 197374, Russian Federation
Withdrawn	Kazan State Medical University	Kazan, 420012, Russian Federation
Completed	LLC Reafan	Novosibirsk, 630099, Russian Federation
Completed	Medical Center "Avicenna"	Novosibirsk, 630099, Russian Federation
Withdrawn	Ural Sci-Res. Inst. of Protection of Motherhood and Infancy	Yekaterinburg, 620028, Russian Federation
Withdrawn	Multiprofile clinic "SOYUZ"	Moscow, 107076, Russian Federation
Completed	Regional perinatal center	Yaroslavl, 150042, Russian Federation
Completed	Krasnoyarsk State Medical University	Krasnoyarsk, 660022, Russian Federation

Primary Outcome

Overall satisfaction rate
5-point Likert item 1.Very satisfied 2.Satisfied 3.Neither satisfied nor dissatisfied 4.Dissatisfied 5.Very dissatisfied
Time Frame:
12 months
Safety Issue:
No

Secondary Outcome

Number of adverse events
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.
Time Frame:
Up to 5 years
Safety Issue:
Yes
Discontinuation rates
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.
Time Frame:
Up to 5 years
Safety Issue:
No
Bleeding pattern
Only during the comparative part of the study
Time Frame:
Up to 12 months
Safety Issue:
No
User satisfaction and bleeding questionnaire
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.
Time Frame:
Up to 12 months
Safety Issue:
No

Trial design

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)

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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