LCS16 vs. COC User Satisfaction and Tolerability Study

Contraception Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074045
• Other study ID #: 17878
• Status: Completed
• Phase: Phase 3
• Start date: March 13, 2017
• Est. completion date: August 5, 2022

Study information

• Verified date: June 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 5, 2022
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

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
• 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

Locations

Country	Name	City	State
Russian Federation	Altai State Medical University	Barnaul
Russian Federation	Scientific Center of family health & human reprod. problems	Irkutsk
Russian Federation	Krasnoyarsk State Medical University	Krasnoyarsk
Russian Federation	City Clinical Hospital #13 Moscow	Moscow
Russian Federation	LLC Reafan	Novosibirsk
Russian Federation	Medical Center "Avicenna"	Novosibirsk
Russian Federation	Smolensk State Medical University	Smolensk
Russian Federation	LLC Medical center PRIME ROSE	St. Petersburg
Russian Federation	Regional perinatal center	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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/Obst

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall satisfaction rate	5-point Likert item; Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied; Very dissatisfied	12 months
Secondary	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
Secondary	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
Secondary	Bleeding pattern	Only during the comparative part of the study	Up to 12 months
Secondary	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

External Links

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