LCS16 vs. COC User Satisfaction and Tolerability Study

NCT03074045 | Completed Phase 3

• 1 other identifier: 17878
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 9

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.

Conditions

Contraception

Keywords

Intrauterine; Birth control

Outcome Measures

Primary Outcomes (1)

• Overall satisfaction rate

  5-point Likert item 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied

  12 months

Secondary Outcomes (4)

• Number of adverse events

  Up to 5 years

• Discontinuation rates

  Up to 5 years

• Bleeding pattern

  Up to 12 months

• User satisfaction and bleeding questionnaire

  Up to 12 months

Study Arms (2)

Test

EXPERIMENTAL

LCS16 (Low-dose LNG IUS)

Drug: Levonorgestrel (Kyleena, BAY86-5028)

Reference

ACTIVE COMPARATOR

COC (Yarina)

Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

Interventions

Levonorgestrel (Kyleena, BAY86-5028) DRUG

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

Test

Ethinyl estradiol and drospirenone (Yarina, BAY86-5131) DRUG

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

Reference

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (9)

Altai State Medical University

Barnaul, 656038, Russia

Location

Scientific Center of family health & human reprod. problems

Irkutsk, 664003, Russia

Location

Krasnoyarsk State Medical University

Krasnoyarsk, 660022, Russia

Location

City Clinical Hospital #13 Moscow

Moscow, 115280, Russia

Location

LLC Reafan

Novosibirsk, 630099, Russia

Location

Medical Center "Avicenna"

Novosibirsk, 630099, Russia

Location

LLC Medical center PRIME ROSE

Saint Petersburg, 197374, Russia

Location

Smolensk State Medical University

Smolensk, 214019, Russia

Location

Regional perinatal center

Yaroslavl, 150042, Russia

Location

Related 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/Obstetrics and Gynecology. 2021; 11: 230-236 (in Russian)

  RESULT

Related 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.

MeSH Terms

Interventions

Levonorgestrel; Ethinyl Estradiol; drospirenone

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: March 13, 2017
• Primary Completion: September 3, 2018
• Study Completion: August 5, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (9)