check_circleStudy 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
  • -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.


  • -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
No
Products
Kyleena (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Scien. Res. Institute of Obsterics, Gyn. & ReproductionSt. Petersburg, 199034, Russian Federation
Completed
City Clinical Hospital #13 MoscowMoscow, 115280, Russian Federation
Withdrawn
Moscow Regional Sc. Res. Institue of Obstetrics & GynecologyMoscow, 101000, Russian Federation
Completed
Smolensk State Medical UniversitySmolensk, 214019, Russian Federation
Completed
Altai State Medical UniversityBarnaul, 656038, Russian Federation
Completed
Scientific Center of family health & human reprod. problemsIrkutsk, 664003, Russian Federation
Completed
LLC Medical center PRIME ROSESt. Petersburg, 197374, Russian Federation
Withdrawn
Kazan State Medical UniversityKazan, 420012, Russian Federation
Completed
LLC ReafanNovosibirsk, 630099, Russian Federation
Completed
Medical Center "Avicenna"Novosibirsk, 630099, Russian Federation
Withdrawn
Ural Sci-Res. Inst. of Protection of Motherhood and InfancyYekaterinburg, 620028, Russian Federation
Withdrawn
Multiprofile clinic "SOYUZ"Moscow, 107076, Russian Federation
Completed
Regional perinatal centerYaroslavl, 150042, Russian Federation
Completed
Krasnoyarsk State Medical UniversityKrasnoyarsk, 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
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding pattern
    Only during the comparative part of the study
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    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
2

Additional Information

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