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CompletedNCT01463254Updated Jul 15, 2013

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

An observational study in Contraception, sponsored by FHI 360. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-15.

Sponsored by FHI 360 · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
724
Ages
18 Years to 44 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • 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
  • ULN upper limit of the normal range
  • WB Western Blot
03

In context

Lead sponsor

FHI 360 is the lead sponsor of 56 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

women using Femplant as a primary method of contraception in Pakistan

Eligibility 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
05

Study design

Time perspective
Prospective
Enrollment
724 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. pregnancy

    measure number of pregnancies while using implant

    Time frame: 12 months

  2. Immediate and Delayed Complications

    Measure Immediate and delayed complications associated with insertion or removal of implant

    Time frame: 12 months

  3. Adverse events

    to record any adverse events associated with the implant

    Time frame: 12 months

  4. Measure number of participants who discontinue from the study

    Measure number of participants who discontinue from the study and the reasons for discontinuation

    Time frame: 12 months

07

Study locations

1 site
  • Marie Stopes Society clinics
    Pakistan, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01463254
Lead sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID)
Responsible party
Sponsor
First posted
Nov 1, 2011
Start date
Oct 2011
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Jul 15, 2013

Study contacts

Paul Feldblum, PhD
study director · FHI 360
Syed Khurram Azmat, MD
principal investigator · Marie Stopes Society, Pakistan
Adrienne Testa
study chair · Marie Stopes Internatioanl

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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