Weight GainPhase 3NCT01461824
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
A Phase 3 study testing Depot medroxyprogesterone acetate (DMPA) in people with Weight Gain and Disorder of Bone Density and Structure, Unspecified, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or… Read more about this study
- Who is it for?
- Ages 12 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Disorder of Bone Density and Structure, Unspecified, Uterine Bleeding
- What is being tested?
- Depot medroxyprogesterone acetate (DMPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2016
- Phase
- Phase 3
- 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 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 12-21 years
- Healthy, post-menarcheal female
- Self-selected to initiate depot medroxyprogesterone acetate (DMPA)
- Willingness to use a barrier method of contraception in addition to DMPA
Who cannot join
- Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney)
- Use of medication known to affect weight or BMD (e.g. corticosteroids)
- DMPA use within the past 12 months
- Pregnancy within the past 6 months
- Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)
- Weight exceeding 450 lbs
- Need for confidential contraceptive care for individuals < 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
Read the detailed description
Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones.
In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.
- Being tested
- Depot medroxyprogesterone acetate (DMPA)
- Keywords
- Birth Control, Contraceptive Methods, Female Contraception, Weight Gain, Bone Density
- Medical subject headings
- Weight Gain, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot medroxyprogesterone acetate (DMPA)Drug
Also called Generic Depo Provera manufactured by Greenstone, LLC
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 150 mg DMPA | Active comparator | Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM Receives: Drug: Depot medroxyprogesterone acetate (DMPA) |
| 104mg DMPA | Experimental | Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM Receives: Drug: Depot medroxyprogesterone acetate (DMPA) |
| 75mg DMPA | Experimental | Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM Receives: Drug: Depot medroxyprogesterone acetate (DMPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Measured: Percent change from baseline to 48 Weeks
Proportion of Participants With >5% Weight Gain at 24 Weeks
Individual subjects will be assessed after their Week 24 visit.
Measured: Week 24
Secondary outcomes (1)
Percent Change in Total Hip BMD From Baseline to 48 Weeks
Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated.
Measured: Percent change from baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2015
- Study completionJul 2016
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 Weight GainStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Andrea Bonny, Nationwide Children's Hospital
- Investigators
- Andrea Bonny, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461824
- Sponsor's protocol ID
- IRB11-00583
- Status last verified
- Mar 2018
- First submitted
- 21 Oct 2011
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
- ClinicalTrials.gov ID
- NCT01461824
- Acronym / sponsor ID
- IRB11-00583
- Keywords
- Birth Control, Contraceptive Methods, Female Contraception, Weight Gain, Bone Density
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Sep 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
Detailed description
Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones.
In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150 mg DMPA | Active comparator | Drug: Depot medroxyprogesterone acetate (DMPA)Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM |
| 104mg DMPA | Experimental | Drug: Depot medroxyprogesterone acetate (DMPA)Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM |
| 75mg DMPA | Experimental | Drug: Depot medroxyprogesterone acetate (DMPA)Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 12-21 years
- Healthy, post-menarcheal female
- Self-selected to initiate depot medroxyprogesterone acetate (DMPA)
- Willingness to use a barrier method of contraception in addition to DMPA
Key exclusion criteria (7 listed)
- Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney)
- Use of medication known to affect weight or BMD (e.g. corticosteroids)
- DMPA use within the past 12 months
- Pregnancy within the past 6 months
- Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)
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 |
|---|---|---|
| Depot medroxyprogesterone acetate (DMPA)Also: Generic Depo Provera manufactured by Greenstone, LLC75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months | Drug | 104mg DMPA, 150 mg DMPA, 75mg DMPA |
Primary outcome
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
Time frame: Percent change from baseline to 48 Weeks
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Proportion of Participants With >5% Weight Gain at 24 Weeks
Time frame: Week 24
Individual subjects will be assessed after their Week 24 visit.
1 secondary outcome
Percent Change in Total Hip BMD From Baseline to 48 Weeks
Time frame: Percent change from baseline to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrea Bonny, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depot medroxyprogesterone acetate (DMPA) in people with Weight Gain and Disorder of Bone Density and Structure, Unspecified, run by Nationwide Children's Hospital at 1 site in United States.
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 7 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 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Apr 2018). 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 in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks (time frame: Percent change from baseline to 48 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2018.