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Completed

NCT Number: NCT01434160

LCS12 Adolescent Study

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.

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Key information

Conditions

Contraception

Age range

12 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sankt Pölten, Lower Austria, Austria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skyla (Levonorgestrel, BAY86-5028)

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Sep 14, 2011
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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