Clinical trial NCT01463254: A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
Official title: A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
ULN upper limit of the normal range
WB Western Blot
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2011-11-01
Enrollment: 724
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women using Femplant as a primary method of contraception in Pakistan

Brief summary: 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.

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

Primary outcomes:
measure: pregnancy
timeFrame: 12 months
measure: Immediate and Delayed Complications
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Measure number of participants who discontinue from the study
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pakistan
country: Pakistan
facility: Marie Stopes Society clinics
Study officials:
affiliation: FHI 360
name: Paul Feldblum, PhD
role: STUDY_DIRECTOR
affiliation: Marie Stopes Society, Pakistan
name: Syed Khurram Azmat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes Internatioanl
name: Adrienne Testa
role: STUDY_CHAIR
References: