Bone Mineral DensityPhase 2NCT00924560

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

A Phase 2 study testing 91-day Levonorgestrel Oral Contraceptive and 28-day Levonorgestrel Oral Contraceptive in people with Bone Mineral Density, run by Duramed Research at 46 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 12 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for: Bone Mineral Density
What is being tested?: 91-day Levonorgestrel Oral Contraceptive and 28-day Levonorgestrel Oral Contraceptive
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,361 participants
Where: 46 sitesUnited States
Study dates: Jun 2009to Aug 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 18 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

46 sites in 1 country.

City, postcode or hospital

46 sites in 1 country

United States46 sites

Teva Investigational Site 021
Baton Rouge, Louisiana
Teva Investigational Site 004
Boynton Beach, Florida
Teva Investigational Site 034
Champaign, Illinois
Teva Investigational Site 032
Charleston, South Carolina
Teva Investigational Site 008
Clearwater, Florida
Teva Investigational Site 033
Cleveland, Ohio
Teva Investigational Site 024
Columbia, South Carolina
Teva Investigational Site 046
Dallas, Texas
Teva Investigational Site 026
DeLand, Florida
Teva Investigational Site 002
Durham, North Carolina
Teva Investigational Site 031
Houston, Texas
Teva Investigational Site 045
Houston, Texas
Teva Investigational Site 043
Kernersville, North Carolina
Teva Investigational Site 027
La Mesa, California
Teva Investigational Site 010
Lawrenceville, New Jersey
Teva Investigational Site 009
Lincoln, Nebraska
Teva Investigational Site 040
Los Angeles, California
Teva Investigational Site 023
Louisville, Kentucky
Teva Investigational Site 012
Medford, Oregon
Teva Investigational Site 001
Miami, Florida
Teva Investigational Site 003
Miami, Florida
Teva Investigational Site 037
Mountain View, California
Teva Investigational Site 044
New Bern, North Carolina
Teva Investigational Site 019
Norfolk, Virginia
Teva Investigational Site 047
North Little Rock, Arkansas
Teva Investigational Site 007
Phoenix, Arizona
Teva Investigational Site 018
Phoenix, Arizona
Teva Investigational Site 035
Pittsburgh, Pennsylvania
Teva Investigational Site 038
Port Jefferson, New York
Teva Investigational Site 039
Pottstown, Pennsylvania
Teva Investigational Site 036
Providence, Rhode Island
Teva Investigational Site 020
Raleigh, North Carolina
Teva Investigational Site 048
Rochester, New York
Teva Investigational Site 015
Salt Lake City, Utah
Teva Investigational Site 013
San Diego, California
Teva Investigational Site 017
San Diego, California
Teva Investigational Site 014
Seattle, Washington
Teva Investigational Site 016
Spokane, Washington
Teva Investigational Site 030
St Louis, Missouri
Teva Investigational Site 028
Tampa, Florida
Teva Investigational Site 025
Torrance, California
Teva Investigational Site 005
Tucson, Arizona
Teva Investigational Site 011
Waco, Texas
Teva Investigational Site 022
Washington D.C., District of Columbia
Teva Investigational Site 041
West Palm Beach, Florida
Teva Investigational Site 006
Winston-Salem, North Carolina

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Bone Mineral Density
Being tested: 91-day Levonorgestrel Oral Contraceptive, 28-day Levonorgestrel Oral Contraceptive
Keywords: Adolescents, Bone Mineral Density, Oral Contraceptive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

91-day Levonorgestrel Oral ContraceptiveDrug
Also called levonorgestrel/ethinyl estradiol, DR-105, Seasonique®
Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
Take 1 tablet daily
28-day Levonorgestrel Oral ContraceptiveDrug
Also called levonorgestrel/ethinyl estradiol, Lessina®
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily

Study groups in NCT00924560
Study group	Role	What they receive
91-day Levonorgestrel Oral Contraceptive	Experimental	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). Receives: Drug: 91-day Levonorgestrel Oral Contraceptive
28-day Levonorgestrel Oral Contraceptive	Active comparator	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). Receives: Drug: 28-day Levonorgestrel Oral Contraceptive
Untreated Control	No intervention	Participants received no oral contraceptives during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)
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%.
Measured: Baseline and Month 12

Secondary outcomes (12)

Change From Baseline in Lumbar Spine Bone Mineral Density
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Density
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Content (BMC)
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Density
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Content (BMC)
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Bone-specific Alkaline Phosphatase
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Serum Deoxypyridinoline
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Serum Osteocalcin
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Serum Procollagen 1 N-terminal Propeptide
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Serum Type I Collagen N-telopeptide
Measured: Baseline, Month 6 and Month 12
Number of Participants With Adverse Events (AEs)
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Aug 2012

First posted19 Jun 2009 (estimated)
Study startJun 2009
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bone Mineral DensityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00924560
Sponsor's protocol ID: DR-105-202
Status last verified: Oct 2014
First submitted: 18 Jun 2009
Last updated: 22 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00924560
Acronym / sponsor ID: DR-105-202
Conditions: Bone Mineral Density
Keywords: Adolescents, Bone Mineral Density, Oral Contraceptive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,361 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 19 Jun 2009 (estimated)
Results: Posted 9 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
91-day Levonorgestrel Oral Contraceptive	Experimental	Drug: 91-day Levonorgestrel Oral ContraceptiveParticipants 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).
28-day Levonorgestrel Oral Contraceptive	Active comparator	Drug: 28-day Levonorgestrel Oral ContraceptiveParticipants 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).
Untreated Control	No intervention	–Participants received no oral contraceptives during the study.

Who may qualify

Ages: 12 to 18 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
91-day Levonorgestrel Oral ContraceptiveAlso: levonorgestrel/ethinyl estradiol, DR-105, Seasonique®Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet. Take 1 tablet daily	Drug	91-day Levonorgestrel Oral Contraceptive
28-day Levonorgestrel Oral ContraceptiveAlso: levonorgestrel/ethinyl estradiol, Lessina®Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily	Drug	28-day Levonorgestrel Oral Contraceptive

Primary outcome

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%.

12 secondary outcomes

Change From Baseline in Lumbar Spine Bone Mineral Density
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Density
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Content (BMC)
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Density
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Content (BMC)
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Bone-specific Alkaline Phosphatase
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Serum Deoxypyridinoline
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Serum Osteocalcin
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Serum Procollagen 1 N-terminal Propeptide
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Serum Type I Collagen N-telopeptide
Time frame: Baseline, Month 6 and Month 12
Number of Participants With Adverse Events (AEs)
Time frame: 12 months

Results and safety

Results posted to the registry on 9 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
91-day Levonorgestrel OC	458	247
28-day Levonorgestrel OC	448	240
Untreated Control	455	372

Primary outcome: Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)

Time frame: Baseline and Month 12. Least squares mean (Standard Error). Unit: percent change

Measure	91-day Levonorgestrel OC n = 238	28-day Levonorgestrel OC n = 229	Untreated Control n = 362
Value	2.26 (0.168)	1.45 (0.171)	2.50 (0.139)

91-day Levonorgestrel OC vs Untreated Control: LS Mean Difference: -0.23 (95% CI -0.67 to 0.20)
28-day Levonorgestrel OC vs Untreated Control: LS Mean Difference: -1.05 (95% CI -1.49 to -0.61)

Population analysed: Per-protocol analysis set, including all participants who received at least 1 dose of study treatment (does not apply to Control group), had both Baseline and one post-baseline assessment via DXA, and who completed all procedures at all scheduled study visits including the 12-month DXA scans, and did not have any major protocol violations.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
91-day Levonorgestrel OC	9 of 421 (2.1%)	156 of 421 (37.1%)	Not reported
28-day Levonorgestrel OC	12 of 412 (2.9%)	160 of 412 (38.8%)	Not reported
Untreated Control	0 of 437 (0%)	196 of 437 (44.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jen Henrick study chair

Teva GBP

46 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00924560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2014.