ContraceptionPADNCT00775047
Pharmacist-Administered Injections for Contraception
A study testing Pharmacist-administered and clinic-administered injections in people with Contraception, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to see if it is a feasible arrangement to have women receive their second and third birth control injection (with Depo-Provera) at a pharmacy compared with receiving it a Planned Parenthood Clinic. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Pharmacist-administered and clinic-administered injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2008
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 y.o., English speaking/reading, presenting to Planned Parenthood to use Depo Provera (restarting, first use, or continuing use)
Who cannot join
- Under 18 years of age, English illiterate (reading and verbal)
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood of Central North Carolina
Chapel Hill, North Carolina, 27514
About this study
Official title: Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial
The purpose of this study is to see if it is a feasible arrangement to have women receive their second and third birth control injection (with Depo-Provera) at a pharmacy compared with receiving it a Planned Parenthood Clinic. Compliance with returning for injections as well as patient satisfaction with the method, providers, and location where injection was received will be assessed and compared between the two sites. The hypothesis is that there will be no difference in return rates for injections at either the pharmacy or the clinic site.
Read the detailed description
Women who want to use or are currently using Depo-Provera for contraception will be randomized to receive their next two injections either back at the Planned Parenthood clinic or at a local pharmacy where pharmacists are trained to give injections. After each injection, women will be asked to complete a questionnaire to assess their attitudes about the method of birth control, their providers, and the location where they received the injection.
- Conditions
- Contraception
- Being tested
- Pharmacist-administered, clinic-administered injections
- Keywords
- depo medroxyprogesterone acetate, Depo Provera, contraceptive compliance, pharmacists, Compliance in receiving additional Depo Provera injections, Satisfaction in receiving Depo Provera injections at a pharmacy compared with usual clinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-administeredOther
Also called SQ Depo-Provera
women will receive their injections at a pharmacy by a clinical pharmacist
clinic-administered injectionsOther
Also called SQ Depo-Provera
women will return for their injections to the clinic where recruitment took place. They will receive one at 3 months and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacy | Experimental | Women receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists Receives: Other: Pharmacist-administered |
| Planned Parenthood clinic | Active comparator | Women receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic. Receives: Other: clinic-administered injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance in returning for 3 month and 6 month injections
Measured: 3 months and 6 months after first injection
Secondary outcomes (1)
Attitudes about clinical setting
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startAug 2006
- Primary completionSep 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Carla Picardo, MD, MPH, Principal investigator, Dept. of Social Medicine, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775047
- Sponsor's protocol ID
- 05-EPID-52
- Acronym
- PAD
- Status last verified
- Oct 2008
- First submitted
- 15 Oct 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00775047
- Acronym / sponsor ID
- PAD / 05-EPID-52
- Conditions
- Contraception
- Keywords
- depo medroxyprogesterone acetate, Depo Provera, contraceptive compliance, pharmacists, Compliance in receiving additional Depo Provera injections, Satisfaction in receiving Depo Provera injections at a pharmacy compared with usual clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Oct 2008 (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 see if it is a feasible arrangement to have women receive their second and third birth control injection (with Depo-Provera) at a pharmacy compared with receiving it a Planned Parenthood Clinic. Compliance with returning for injections as well as patient satisfaction with the method, providers, and location where injection was received will be assessed and compared between the two sites. The hypothesis is that there will be no difference in return rates for injections at either the pharmacy or the clinic site.
Detailed description
Women who want to use or are currently using Depo-Provera for contraception will be randomized to receive their next two injections either back at the Planned Parenthood clinic or at a local pharmacy where pharmacists are trained to give injections. After each injection, women will be asked to complete a questionnaire to assess their attitudes about the method of birth control, their providers, and the location where they received the injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacy | Experimental | Other: Pharmacist-administeredWomen receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists |
| Planned Parenthood clinic | Active comparator | Other: clinic-administered injectionsWomen receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 y.o., English speaking/reading, presenting to Planned Parenthood to use Depo Provera (restarting, first use, or continuing use)
Key exclusion criteria (1 listed)
- Under 18 years of age, English illiterate (reading and verbal)
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 |
|---|---|---|
| Pharmacist-administeredAlso: SQ Depo-Proverawomen will receive their injections at a pharmacy by a clinical pharmacist | Other | Pharmacy |
| clinic-administered injectionsAlso: SQ Depo-Proverawomen will return for their injections to the clinic where recruitment took place. They will receive one at 3 months and 6 months. | Other | Planned Parenthood clinic |
Primary outcome
Compliance in returning for 3 month and 6 month injections
Time frame: 3 months and 6 months after first injection
1 secondary outcome
Attitudes about clinical setting
Time frame: 3 months and 6 months
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 17 Oct 2008.
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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.
Carla Picardo, MD, MPH principal investigator
Dept. of Social Medicine, University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-administered and clinic-administered injections in people with Contraception, run by University of North Carolina, Chapel Hill 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 1 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 17 Oct 2008. 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?
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?
Compliance in returning for 3 month and 6 month injections (time frame: 3 months and 6 months after first injection). 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 17 Oct 2008.