Status:
COMPLETED
LCS12 Adolescent Study
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
12-17 years
Phase:
PHASE3
Brief Summary
The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy...
Eligibility Criteria
Inclusion
- The subject has signed and dated the informed consent form (ICF)
- The subject is female, generally healthy, post-menarcheal, nulliparous or parous, requiring contraception, and is under 18 years of age at the Screening visit
- The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days)
- In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of levonorgestrel intrauterine contraceptive system (LCS12) (uterine sound depth 6-10 cm)
- Has clinically normal safety laboratory results
- The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system)
- The subject is willing and able to attend the scheduled study visits and to comply with the study procedures
Exclusion
- Known or suspected pregnancy or is lactating
- Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1
- History of ectopic pregnancies
- Infected abortion or postpartum endometritis less than 3 months before Visit 1
- Abnormal uterine bleeding of unknown origin
- Any lower genital tract infection (until successfully treated)
- Acute or history of recurrent pelvic inflammatory disease
- Congenital or acquired uterine anomaly
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01434160
Start Date
September 1 2011
End Date
May 1 2015
Last Update
July 27 2015
Active Locations (41)
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1
Sankt Pölten, Lower Austria, Austria, 3100
2
Bregenz, Austria, 6900
3
Vienna, Austria, 1070
4
Voitsberg, Austria, 8570