Trial Condition(s):
LCS16 vs. COC user satisfaction and tolerability study
17878
Not Available
Not Available
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.
-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.
-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.
Locations | |
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Locations City Clinical Hospital #13 Moscow, Russia, 115280 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Smolensk State Medical University Smolensk, Russia, 214019 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Altai State Medical University Barnaul, Russia, 656038 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Scientific Center of family health & human reprod. problems Irkutsk, Russia, 664003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations LLC Medical center PRIME ROSE St. Petersburg, Russia, 197374 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations LLC Reafan Novosibirsk, Russia, 630099 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center "Avicenna" Novosibirsk, Russia, 630099 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Regional perinatal center Yaroslavl, Russia, 150042 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krasnoyarsk State Medical University Krasnoyarsk, Russia, 660022 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Not Available