Clinical trial NCT03074045: LCS16 vs. COC User Satisfaction and Tolerability Study
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Intrauterine
Birth control
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall satisfaction rate
timeFrame: 12 months
Secondary outcomes:
measure: Number of adverse events
timeFrame: Up to 5 years
measure: Discontinuation rates
timeFrame: Up to 5 years
measure: Bleeding pattern
timeFrame: Up to 12 months
measure: User satisfaction and bleeding questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Altai State Medical University
city: Irkutsk
country: Russian Federation
facility: Scientific Center of family health & human reprod. problems
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #13 Moscow
city: Novosibirsk
country: Russian Federation
facility: LLC Reafan
city: Novosibirsk
country: Russian Federation
facility: Medical Center "Avicenna"
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: St. Petersburg
country: Russian Federation
facility: LLC Medical center PRIME ROSE
city: Yaroslavl
country: Russian Federation
facility: Regional perinatal center
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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)