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

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Bone Mineral Density

Treatments: Drug: 91-day Levonorgestrel Oral Contraceptive; Drug: 28-day Levonorgestrel Oral Contraceptive

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924560

DR-105-202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,361 patients

Sex: Female

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,361 participants in 3 patient groups

91-day Levonorgestrel Oral Contraceptive

Experimental group

Description:

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).

Treatment:

Drug: 91-day Levonorgestrel Oral Contraceptive

28-day Levonorgestrel Oral Contraceptive

Active Comparator group

Description:

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).

Treatment:

Drug: 28-day Levonorgestrel Oral Contraceptive

Untreated Control

No Intervention group

Description:

Participants received no oral contraceptives during the study.