ContraceptionNCT01143207
PK of Depo SubQ Injected in the Upper Arm
A study testing Medroxyprogesterone acetate in people with Contraception, run by FHI 360 at 1 site in United States.
Trial summary
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Medroxyprogesterone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2012
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40
- negative pregnancy test on day of injection
- not wishing to become pregnant in the next 12 months
- at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD)
- body mass index of 18-30
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception
Read the detailed description
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm
- Conditions
- Contraception
- Being tested
- Medroxyprogesterone acetate
- Keywords
- AE adverse event, DCF data collection forms, DMC Data Monitoring Committee, FDA U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU International units, mg milligram(s), SAE serious adverse event, µg microgram, ULN upper limit of the normal range
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone acetateDrug
Also called Depo-SubQ Provera 104
Injectable hormonal contraceptive
| Study group | Role | What they receive |
|---|---|---|
| Medroxyprogesterone acetate | Experimental | Single injection of Medroxyprogesterone acetate (hormonal contraceptive) Receives: Drug: Medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
Measured: 120 days following injection
Tmax (Time to Cmax)
Measured: 120 days following injection
AUC 0-91 (Area Under Curve)
Measured: first 91 days following injection
MPA Concentration at Day 91 (C91)
Measured: day 91 after first injection
MPA Concentration at Day 104 (C104)
Measured: day 104 after injection
MPA Concentration at Day 120 (C120)
Measured: day 120 after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionOct 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 ContraceptionStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Virginia Medical School
- Responsible party
- Sponsor
- Investigators
- David Archer, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143207
- Sponsor's protocol ID
- 10206
- Status last verified
- Aug 2013
- First submitted
- 7 Jun 2010
- Last updated
- 19 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm
- ClinicalTrials.gov ID
- NCT01143207
- Acronym / sponsor ID
- 10206
- Conditions
- Contraception
- Keywords
- AE adverse event, DCF data collection forms, DMC Data Monitoring Committee, FDA U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Eastern Virginia Medical School
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 19 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception
Detailed description
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medroxyprogesterone acetate | Experimental | Drug: Medroxyprogesterone acetateSingle injection of Medroxyprogesterone acetate (hormonal contraceptive) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40
- negative pregnancy test on day of injection
- not wishing to become pregnant in the next 12 months
- at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD)
- body mass index of 18-30
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Medroxyprogesterone acetateAlso: Depo-SubQ Provera 104Injectable hormonal contraceptive | Drug | Medroxyprogesterone acetate |
Primary outcome
Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
Time frame: 120 days following injection
Tmax (Time to Cmax)
Time frame: 120 days following injection
AUC 0-91 (Area Under Curve)
Time frame: first 91 days following injection
MPA Concentration at Day 91 (C91)
Time frame: day 91 after first injection
MPA Concentration at Day 104 (C104)
Time frame: day 104 after injection
MPA Concentration at Day 120 (C120)
Time frame: day 120 after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
- 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.
David Archer, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medroxyprogesterone acetate in people with Contraception, run by FHI 360 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 5 inclusion and 1 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 19 Aug 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2013). 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?
Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) (time frame: 120 days following injection). The study lists 6 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 19 Aug 2013.