LCS12 Adolescent Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01434160
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):

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, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be enrolled into the study.

Duration of study treatment is approximately 12 months with an option to continue the use of the contraceptive system up to three years if the woman is willing to continue the use after the first 12 months.

The incidence of adverse events over 12 month treatment period will be the main outcome of this study. Also the efficacy (number of pregnancies), discontinuation rate and pharmacokinetics will be evaluated.

Condition or disease Intervention/treatment Phase
Contraception Drug: Skyla (Levonorgestrel, BAY86-5028) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multi-center, Single-arm Study to Assess the Safety, Efficacy, Discontinuation Rate and Pharmacokinetics of the Low-dose Levonorgestrel Intrauterine Contraceptive System (LCS12) in Post-menarcheal Female Adolescents Under 18 Years of Age for 1 Year, and an Optional 2-year Extension Phase
Study Start Date : September 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Skyla (Levonorgestrel, BAY86-5028)
Levonorgestrel intrauterine contraceptive system (LCS12) insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 3 years will be offered for all subjects completing 12 month treatment time.

Primary Outcome Measures :
  1. Number of adverse events reported by study subjects [ Time Frame: 12 months treatment period ]
  2. Portion of subjects reporting adverse events [ Time Frame: 12 months treatment period ]

Secondary Outcome Measures :
  1. Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied) [ Time Frame: 12 months treatment period ]
  2. Pearl index [ Time Frame: 12 months treatment period ]
  3. Bleeding patterns collected from patients' diary [ Time Frame: 12 months treatment period ]
  4. Concentration of Levonorgestrel in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ]
  5. Concentration of sex hormone binding globulin in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ]
  6. Discontinuation rate [ Time Frame: 12 months treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01434160

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01434160     History of Changes
Other Study ID Numbers: 14371
2011-002065-37 ( EudraCT Number )
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

Keywords provided by Bayer:

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral