OsteoporosisPhase 2NCT00320567
The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa
A Phase 2 study testing norgestimate/ethinyl estradiol in people with Osteoporosis, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
Trial summary
The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with anorexia nervosa. Read more about this study
- Who is it for?
- Ages Up to 17 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- norgestimate/ethinyl estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Up to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Patients must have a monthly period
- health status consistent with anorexia nervosa
- meet the modified DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) guideline for anorexia nervosa
- must discontinue the following prior to Baseline visit: hormonal contraceptives for 3 months
- hormonal intrauterine devices (IUDs) for 1 month
- NORPLANT for 3 months
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- DepoProvera and other depot hormone injections, for 6 months
- Lupron, Lupron Depot 3.75 mg and 7.5 mg, Synarel, Zoladex, Cetrotide for 3 months
- Lupron Depot 11.25 mg, 15 mg, 22.5 mg, 30 mg for 6 months
- non-smoker or smoking <= 15 cigarettes per day
- must agree to use reliable non-hormonal alternate method of birth control during the study
Who cannot join
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products, known or suspected carcinoma of any body system, diabetes mellitus with vascular involvement
- recent history of alcohol or substance abuse
- patients with primary amenorrhea (abnormal suppression or absence of menstruation) who in the opinion of the physician, are not appropriate candidates for hormonal therapy (eg, have not grown to an acceptable adult height)
- subjects who are suicidal
- patients who have received any experimental drug and/or used any experimental device within 30 days before the start of the study.
About this study
Official title: The Effect of Ortho Tri-Cyclen on Bone Mineral Density in Pediatric Subjects With Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study
The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with anorexia nervosa.
Read the detailed description
Although oral contraceptives are prescribed in an effort to prevent bone loss in adolescents with anorexia nervosa, there have been no previous definitive placebo-controlled studies evaluating the effectiveness of oral contraceptive treatment on bone mineral density in pediatric females with anorexia nervosa. This is a randomized (patients are assigned different treatments based on chance), multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study to evaluate the bone mineral density in pediatric patients with anorexia nervosa following treatment with norgestimate/ethinyl estradiol or placebo for 13 consecutive 28-day cycles. Norgestimate/Ethinyl Estradiol is packaged in a 28-day blistercard. Each tablet contains the following:
- Days 1-7 0.180 mg norgestimate/0.035 mg ethinyl estradiol b) Days 8-14 0.215 mg norgestimate/0.035 mg ethinyl estradiol c) Days 15-21 0.250 mg norgestimate/0.035 mg ethinyl estradiol d) Days 22-28 inactive tablets;One tablet is to be taken once daily by mouth. After 28 days, the next cycle is started the following day without interruption. Color-matched placebo tablets are identically pack
- Conditions
- Osteoporosis
- Being tested
- norgestimate/ethinyl estradiol
- Keywords
- osteoporosis, anorexia nervosa, pediatric
- Medical subject headings
- Osteoporosis, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norgestimate/ethinyl estradiolDrug
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | norgestimate/ethinyl estradiol Receives: Drug: norgestimate/ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in total lumbar spine (L1-L4) bone mineral density from baseline to Cycle 6 (Visit 6).
Secondary outcomes (1)
The percent change in total lumbar spine BMD from baseline to Cycle 6. The change and percent change in total lumbar spine BMD from baseline to Cycle 13. The change and percent change in total hip BMD from baseline to Cycle 6 and Cycle 13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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
- Double blind
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320567
- Sponsor's protocol ID
- CR008332
- Status last verified
- Jun 2011
- First submitted
- 28 Apr 2006
- Last updated
- 1 Jul 2011
- Results posted
- No
Publications
Strokosch GR, Friedman AJ, Wu SC, Kamin M. Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study. J Adolesc Health. 2006 Dec;39(6):819-27. doi: 10.1016/j.jadohealth.2006.09.010.
PubMed 17116511
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ortho Tri-Cyclen on Bone Mineral Density in Pediatric Subjects With Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00320567
- Acronym / sponsor ID
- CR008332
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, anorexia nervosa, pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Industry (pharma, biotech, devices)
- Study completion
- Apr 2004 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with anorexia nervosa.
Detailed description
Although oral contraceptives are prescribed in an effort to prevent bone loss in adolescents with anorexia nervosa, there have been no previous definitive placebo-controlled studies evaluating the effectiveness of oral contraceptive treatment on bone mineral density in pediatric females with anorexia nervosa. This is a randomized (patients are assigned different treatments based on chance), multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study to evaluate the bone mineral density in pediatric patients with anorexia nervosa following treatment with norgestimate/ethinyl estradiol or placebo for 13 consecutive 28-day cycles. Norgestimate/Ethinyl Estradiol is packaged in a 28-day blistercard. Each tablet contains the following:
- Days 1-7 0.180 mg norgestimate/0.035 mg ethinyl estradiol b) Days 8-14 0.215 mg norgestimate/0.035 mg ethinyl estradiol c) Days 15-21 0.250 mg norgestimate/0.035 mg ethinyl estradiol d) Days 22-28 inactive tablets;One tablet is to be taken once daily by mouth. After 28 days, the next cycle is started the following day without interruption. Color-matched placebo tablets are identically pack
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: norgestimate/ethinyl estradiolnorgestimate/ethinyl estradiol |
Who may qualify
- Ages
- Up to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patients must have a monthly period
- health status consistent with anorexia nervosa
- meet the modified DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) guideline for anorexia nervosa
- must discontinue the following prior to Baseline visit: hormonal contraceptives for 3 months
- hormonal intrauterine devices (IUDs) for 1 month
Key exclusion criteria (5 listed)
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products, known or suspected carcinoma of any body system, diabetes mellitus with vascular involvement
- recent history of alcohol or substance abuse
- patients with primary amenorrhea (abnormal suppression or absence of menstruation) who in the opinion of the physician, are not appropriate candidates for hormonal therapy (eg, have not grown to an acceptable adult height)
- subjects who are suicidal
- patients who have received any experimental drug and/or used any experimental device within 30 days before the start of the study.
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 |
|---|---|---|
| norgestimate/ethinyl estradiol | Drug | 001 |
Primary outcome
The change in total lumbar spine (L1-L4) bone mineral density from baseline to Cycle 6 (Visit 6).
1 secondary outcome
The percent change in total lumbar spine BMD from baseline to Cycle 6. The change and percent change in total lumbar spine BMD from baseline to Cycle 13. The change and percent change in total hip BMD from baseline to Cycle 6 and Cycle 13.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Results publication: PubMed 17116511Strokosch GR, Friedman AJ, Wu SC, Kamin M. Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study. J Adolesc Health. 2006 Dec;39(6):819-27. doi: 10.1016/j.jadohealth.2006.09.010.
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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.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing norgestimate/ethinyl estradiol in people with Osteoporosis, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
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 11 inclusion and 5 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 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in total lumbar spine (L1-L4) bone mineral density from baseline to Cycle 6 (Visit 6).. 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 NCT00320567, which also lists 1 linked publication.
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 1 Jul 2011.