LCS16 vs. COC User Satisfaction and Tolerability Study

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)

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Levonorgestrel (Kyleena, BAY86-5028); Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Barnaul, Russian Federation, 656038
    • Altai State Medical University
  • Irkutsk, Russian Federation, 664003
    • Scientific Center of family health & human reprod. problems
  • Krasnoyarsk, Russian Federation, 660022
    • Krasnoyarsk State Medical University
  • Moscow, Russian Federation, 115280
    • City Clinical Hospital #13 Moscow
  • Novosibirsk, Russian Federation, 630099
    • LLC Reafan
  • Novosibirsk, Russian Federation, 630099
    • Medical Center "Avicenna"
  • Smolensk, Russian Federation, 214019
    • Smolensk State Medical University
  • St. Petersburg, Russian Federation, 197374
    • LLC Medical center PRIME ROSE
  • Yaroslavl, Russian Federation, 150042
    • Regional perinatal center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction rate	5-point Likert item; Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied; Very dissatisfied	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years
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.	Up to 5 years
Bleeding pattern	Only during the comparative part of the study	Up to 12 months
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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

General Publications

• Suturina L.V., Dikke G.B. Experience in the use of low-dosed levonorgestrelcontaining intrauterine system Kyleena LNG and combined oral contraceptive containing 30 mcg ethinyl estradiol and 3 mg drospirenone in young women. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2021; 11: 230-236 (in Russian)

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): September 3, 2018
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Birth control; Intrauterine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Natriuretic Agents; Diuretics; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Levonorgestrel; Estradiol; Ethinyl Estradiol; Drospirenone
• Other Study ID Numbers: 17878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No