Trial Condition(s):

Contraception

LCS16 vs. COC user satisfaction and tolerability study

Bayer Identifier:

17878

ClinicalTrials.gov Identifier:

NCT03074045

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
145
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Kyleena (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

City Clinical Hospital #13 Moscow

Moscow, Russia, 115280

Status
Completed
 
Locations

Smolensk State Medical University

Smolensk, Russia, 214019

Status
Completed
 
Locations

Altai State Medical University

Barnaul, Russia, 656038

Status
Completed
 
Locations

Scientific Center of family health & human reprod. problems

Irkutsk, Russia, 664003

Status
Completed
 
Locations

LLC Medical center PRIME ROSE

St. Petersburg, Russia, 197374

Status
Completed
 
Locations

LLC Reafan

Novosibirsk, Russia, 630099

Status
Completed
 
Locations

Medical Center "Avicenna"

Novosibirsk, Russia, 630099

Status
Completed
 
Locations

Regional perinatal center

Yaroslavl, Russia, 150042

Status
Completed
 
Locations

Krasnoyarsk State Medical University

Krasnoyarsk, Russia, 660022

Status
Completed
 

Trial Design