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A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01463254
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : July 15, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.

Condition or disease
Contraception

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

Study Type : Observational
Actual Enrollment : 724 participants
Time Perspective: Prospective
Official Title: A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
Study Start Date : October 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. pregnancy [ Time Frame: 12 months ]
    measure number of pregnancies while using implant

  2. Immediate and Delayed Complications [ Time Frame: 12 months ]
    Measure Immediate and delayed complications associated with insertion or removal of implant

  3. Adverse events [ Time Frame: 12 months ]
    to record any adverse events associated with the implant

  4. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
women using Femplant as a primary method of contraception in Pakistan
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463254


Locations
Pakistan
Marie Stopes Society clinics
Pakistan, Pakistan
Sponsors and Collaborators
FHI 360
United States Agency for International Development (USAID)
Investigators
Study Director: Paul Feldblum, PhD FHI 360
Principal Investigator: Syed Khurram Azmat, MD Marie Stopes Society, Pakistan
Study Chair: Adrienne Testa Marie Stopes Internatioanl
More Information

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01463254     History of Changes
Other Study ID Numbers: 10231
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Keywords provided by FHI 360:
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
ULN upper limit of the normal range
WB Western Blot