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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
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
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
Altai State Medical University
Barnaul, Russia
Scientific Center of family health & human reprod. problems
Irkutsk, Russia
Krasnoyarsk State Medical University
Krasnoyarsk, Russia
City Clinical Hospital #13 Moscow
Moscow, Russia
Overall satisfaction rate
5-point Likert item 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied
Time frame: 12 months
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.
Time frame: 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.
Time frame: Up to 5 years
Bleeding pattern
Only during the comparative part of the study
Time frame: 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.
Time frame: Up to 12 months
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LLC Reafan
Novosibirsk, Russia
Medical Center "Avicenna"
Novosibirsk, Russia
LLC Medical center PRIME ROSE
Saint Petersburg, Russia
Smolensk State Medical University
Smolensk, Russia
Regional perinatal center
Yaroslavl, Russia