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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01463254

Enrollment

724

Registered

2011-11-01

Start date

2011-10-31

Completion date

2013-02-28

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
pregnancy	12 months	measure number of pregnancies while using implant
Immediate and Delayed Complications	12 months	Measure Immediate and delayed complications associated with insertion or removal of implant
Adverse events	12 months	to record any adverse events associated with the implant
Measure number of participants who discontinue from the study	12 months	Measure number of participants who discontinue from the study and the reasons for discontinuation

Countries

Pakistan

Outcome results