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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00924560
First received: June 18, 2009
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Bone Mineral Density
Drug: 91-day Levonorgestrel Oral Contraceptive
Drug: 28-day Levonorgestrel Oral Contraceptive
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Change From Baseline in Lumbar Spine Bone Mineral Density [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

  • Change From Baseline in Lumbar Spine Bone Mineral Content (BMC) [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.

  • Change From Baseline in Proximal Femur Bone Mineral Density [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

  • Change From Baseline in Proximal Femur Bone Mineral Content (BMC) [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.

  • Change From Baseline in Total Body Bone Mineral Density [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

  • Change From Baseline in Total Body Bone Mineral Content (BMC) [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.

  • Change From Baseline in Bone-specific Alkaline Phosphatase [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Deoxypyridinoline [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Osteocalcin [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Procollagen 1 N-terminal Propeptide [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Type I Collagen N-telopeptide [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.


Enrollment: 1361
Study Start Date: June 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 91-day Levonorgestrel Oral Contraceptive
Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
Drug: 91-day Levonorgestrel Oral Contraceptive

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®
Active Comparator: 28-day Levonorgestrel Oral Contraceptive
Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
Drug: 28-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Other Names:
  • levonorgestrel/ethinyl estradiol
  • Lessina®
No Intervention: Untreated Control
Participants received no oral contraceptives during the study.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924560

  Show 46 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Jen Henrick Teva GBP
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00924560     History of Changes
Other Study ID Numbers: DR-105-202
Study First Received: June 18, 2009
Results First Received: October 3, 2014
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Adolescents
Bone Mineral Density
Oral Contraceptive

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Levonorgestrel
Polyestradiol phosphate
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015