Long-term and Permanent Contraceptive MethodsNCT01200576
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
An observational study of Long-term and Permanent Contraceptive Methods, run by FHI 360 at 1 site in Madagascar.
Trial summary
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Long-term and Permanent Contraceptive Methods
- How many people
- 621 participants
- Where
- 1 siteMadagascar
- Study dates
- Oct 2010to Mar 2012
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: healthy women of any age
Who may be able to join
- be a participant of the MSM service evaluation and continue using Zarin at 3 months
- agree at the time of Zarin insertion to be contacted regarding an opportunity to participate in more research related to the implant
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Madagascar1 site
Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics
Madagascar
About this study
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.
Read the detailed description
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.
- Keywords
- CRF: Case Report Form, DM: Data Management, FHI: FHI (formerly known as Family Health International), IRB: Institutional Review Board, IUD: Intra-uterine Device, LTPM: Long-term and Permanent Contraceptive Methods, MSI: Marie Stopes International, MSM: Marie Stopes Madagascar, PHSC: Protection of Human Subjects Committee, PI: Principal Investigator, SAE: Serious Adverse Event, Sino-Implant (II), SOP: Standard Operating Procedure, Zarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative probability of pregnancy through one year
Measured: 1 year
Prevalence and incidence rate of adverse events
Measured: 1 year
Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal
Measured: 1 year
The cumulative probability of early discontinuation through one year
Measured: 1 year
Reasons for discontinuation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term and Permanent Contraceptive MethodsStudies 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
- Observational
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Marie Stopes International
- Responsible party
- Sponsor
- Investigators
- Odile Hanitriniaina, MD, Principal investigator, Marie Stopes InternationalKristen Hopkins, Study chair, Marie Stopes InternationalTania Boler, Principal investigator, Marie Stopes InternationalMarkus Steiner, Ph.D., Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200576
- Sponsor's protocol ID
- 10225
- Status last verified
- Mar 2013
- First submitted
- 10 Sep 2010
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
- ClinicalTrials.gov ID
- NCT01200576
- Acronym / sponsor ID
- 10225
- Keywords
- CRF: Case Report Form, DM: Data Management, FHI: FHI (formerly known as Family Health International), IRB: Institutional Review Board, IUD: Intra-uterine Device, LTPM: Long-term and Permanent Contraceptive Methods, MSI: Marie Stopes International, MSM: Marie Stopes Madagascar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Marie Stopes International
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Sep 2010 (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.
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.
Detailed description
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –healthy volunteers |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- healthy women of any age
Key inclusion criteria (2 listed)
- be a participant of the MSM service evaluation and continue using Zarin at 3 months
- agree at the time of Zarin insertion to be contacted regarding an opportunity to participate in more research related to the implant
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.
Primary outcome
The cumulative probability of pregnancy through one year
Time frame: 1 year
Prevalence and incidence rate of adverse events
Time frame: 1 year
Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal
Time frame: 1 year
The cumulative probability of early discontinuation through one year
Time frame: 1 year
Reasons for discontinuation
Time frame: 1 year
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 29 Mar 2013.
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.
Odile Hanitriniaina, MD principal investigator
Marie Stopes International
Kristen Hopkins study chair
Marie Stopes International
Tania Boler principal investigator
Marie Stopes International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term and Permanent Contraceptive Methods, run by FHI 360 at 1 site in Madagascar.
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 2 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 29 Mar 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 Madagascar. 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?
The cumulative probability of pregnancy through one year (time frame: 1 year). The study lists 5 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 29 Mar 2013.