ContraceptionNCT01463254
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
An observational study of Contraception, run by FHI 360 at 1 site in Pakistan.
Trial summary
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 724 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2011to Feb 2013
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women using Femplant as a primary method of contraception in Pakistan
Who may be able to join
- To be eligible for inclusion, a woman must:
- be aged 18-44 years, inclusive
- be willing to sign an informed consent document
- agree to return for follow-up visits
- have decided to receive Femplant as a method of contraception and met the clinic criteria for eligibility of this method of contraception
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
Read the detailed description
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. It will be conducted in close collaboration with the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie Stopes Society clinics that have experience with implants and sufficient expected flow of implant users per month. We will enroll a total of 600 women divided into two cohorts in this one-year prospective study:
- a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrolment; and
- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant
The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Femplant services.
- Conditions
- Contraception
- Keywords
- Femplant, AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU international units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram
- Medical subject headings
- Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| Surveillance | - a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant | |
| Prospective | a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
measure number of pregnancies while using implant
Measured: 12 months
Immediate and Delayed Complications
Measure Immediate and delayed complications associated with insertion or removal of implant
Measured: 12 months
Adverse events
to record any adverse events associated with the implant
Measured: 12 months
Measure number of participants who discontinue from the study
Measure number of participants who discontinue from the study and the reasons for discontinuation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Paul Feldblum, PhD, Study director, FHI 360Syed Khurram Azmat, MD, Principal investigator, Marie Stopes Society, PakistanAdrienne Testa, Study chair, Marie Stopes Internatioanl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463254
- Sponsor's protocol ID
- 10231
- Status last verified
- Jul 2013
- First submitted
- 13 Oct 2011
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 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 Femplant in Pakistan
- ClinicalTrials.gov ID
- NCT01463254
- Acronym / sponsor ID
- 10231
- Conditions
- Contraception
- Keywords
- Femplant, AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Nov 2011 (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 will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
Detailed description
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. It will be conducted in close collaboration with the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie Stopes Society clinics that have experience with implants and sufficient expected flow of implant users per month. We will enroll a total of 600 women divided into two cohorts in this one-year prospective study:
- a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrolment; and
- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant
The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Femplant services.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance | – | –- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant |
| Prospective | – | –a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women using Femplant as a primary method of contraception in Pakistan
Key inclusion criteria (5 listed)
- To be eligible for inclusion, a woman must:
Key exclusion criteria (0 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
pregnancy
Time frame: 12 months
measure number of pregnancies while using implant
Immediate and Delayed Complications
Time frame: 12 months
Measure Immediate and delayed complications associated with insertion or removal of implant
Adverse events
Time frame: 12 months
to record any adverse events associated with the implant
Measure number of participants who discontinue from the study
Time frame: 12 months
Measure number of participants who discontinue from the study and the reasons for discontinuation
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 15 Jul 2013.
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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.
Paul Feldblum, PhD study director
FHI 360
Syed Khurram Azmat, MD principal investigator
Marie Stopes Society, Pakistan
Adrienne Testa study chair
Marie Stopes Internatioanl
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 Contraception, run by FHI 360 at 1 site in Pakistan.
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 0 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 15 Jul 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 Pakistan. 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?
pregnancy (time frame: 12 months). The study lists 4 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 15 Jul 2013.