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Completed

NCT Number: NCT00924560

A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females

This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.

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Key information

Conditions

Bone Mineral Density

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Teva Investigational Site 007, Phoenix, Arizona, United States

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About this study

Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study for each study participant will be approximately 13 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy postmenarchal adolescent female 12-18 years old, non-pregnant, nonlactating
  • Regular spontaneous menstrual cycles
  • Body mass index (BMI): 18 kg/m² to <30 kg/m², weight < 200 lbs
  • Others as dictated by the Food and Drug Administration (FDA)-approved protocol

Exclusion criteria

  • Any contraindication to the use of oral contraceptives
  • History of previous clinically significant adverse event while taking hormonal contraceptives
  • Use of any medication which could significantly interfere with study assessments
  • Others as dictated by FDA-approved protocol

Treatment and study plan

91-day Levonorgestrel Oral Contraceptive

Drug

Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.

Take 1 tablet daily

Other names: levonorgestrel/ethinyl estradiol, DR-105, Seasonique®

28-day Levonorgestrel Oral Contraceptive

Drug

Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily

Other names: levonorgestrel/ethinyl estradiol, Lessina®

Primary outcomes

  1. Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)

    Time frame: Baseline and Month 12

    Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

    Percent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline * 100%.

Secondary outcomes

  1. Change From Baseline in Lumbar Spine Bone Mineral Density

    Time frame: Baseline, Month 6 and Month 12

    Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

  2. Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)

    Time frame: Baseline, Month 6 and Month 12

    Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.

  3. Change From Baseline in Proximal Femur Bone Mineral Density

    Time frame: Baseline, Month 6 and Month 12

    Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

  4. Change From Baseline in Proximal Femur Bone Mineral Content (BMC)

    Time frame: Baseline, Month 6 and Month 12

    Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.

  5. Change From Baseline in Total Body Bone Mineral Density

    Time frame: Baseline, Month 6 and Month 12

    Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

  6. Change From Baseline in Total Body Bone Mineral Content (BMC)

    Time frame: Baseline, Month 6 and Month 12

    Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.

  7. Change From Baseline in Bone-specific Alkaline Phosphatase

    Time frame: Baseline, Month 6 and Month 12

  8. Change From Baseline in Serum Deoxypyridinoline

    Time frame: Baseline, Month 6 and Month 12

  9. Change From Baseline in Serum Osteocalcin

    Time frame: Baseline, Month 6 and Month 12

  10. Change From Baseline in Serum Procollagen 1 N-terminal Propeptide

    Time frame: Baseline, Month 6 and Month 12

  11. Change From Baseline in Serum Type I Collagen N-telopeptide

    Time frame: Baseline, Month 6 and Month 12

  12. Number of Participants With Adverse Events (AEs)

    Time frame: 12 months

    An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.

    A severe AE is defined as incapacitating, with inability to perform usual activities.

    A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:

    • fatal or life-threatening;
    • required or prolonged inpatient hospitalization;
    • resulted in persistent or significant disability/incapacity;
    • congenital anomaly or birth defect;
    • important medical event.

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Multicenter, Open-Label, Randomized, Controlled Study to Compare the Effects on Bone Mineral Density of DR-105 and a 28-Day Cycle Oral Contraceptive Regimen in Healthy, Postmenarchal, Adolescent Females

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 19, 2009
Registry last updated
Oct 22, 2014

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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