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

NCT01463254 | Completed

• 1 other identifier: 10231
• Study Type: observational
• Target: 724
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (4)

• pregnancy

  measure number of pregnancies while using implant

  12 months

• Immediate and Delayed Complications

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

  12 months

• Adverse events

  to record any adverse events associated with the implant

  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

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women using Femplant as a primary method of contraception in Pakistan

You may qualify if:

• 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

Sponsors & Collaborators

• FHI 360: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Marie Stopes Society clinics

Pakistan, Pakistan, Pakistan

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Paul Feldblum, PhD

  FHI 360

  STUDY DIRECTOR

• Syed Khurram Azmat, MD

  Marie Stopes Society, Pakistan

  PRINCIPAL INVESTIGATOR

• Adrienne Testa

  Marie Stopes Internatioanl

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

PA (1)