A Prospective Observational Study of the Performance of Zarin in Kenya
|
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: NCT01334190 |
|
Recruitment Status
:
Completed
First Posted
: April 13, 2011
Last Update Posted
: July 2, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators 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 enrollment; and
- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment 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 Zarin services.
| Condition or disease |
|---|
| Contraceptive Usage |
A non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators 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 enrollment; and
- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment 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 Zarin services.
| Study Type : | Observational |
| Actual Enrollment : | 602 participants |
| Official Title: | A Prospective Observational Study of the Performance of Zarin in Kenya |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2013 |
- The cumulative probability of pregnancy [ Time Frame: 1 year ]
- Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal [ Time Frame: 1 year ]
- Prevalence and incidence rate of adverse events [ Time Frame: 1 year ]
- The cumulative probability of early discontinuation of Zarin through one year [ Time Frame: 1 year ]
- Reasons for discontinuation [ Time Frame: 1 year ]
- Level of women's satisfaction with Zarin services [ Time Frame: 1 year ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- be aged 18-44 years, inclusive
- be willing to sign an informed consent document
- be willing to give contact information for follow up
- agree to return for follow-up visits
- have decided to receive Zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception
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): NCT01334190
| Kenya | |
| FHI | |
| Nairobi, Kenya | |
| Principal Investigator: | Vera Halpern, MD | FHI 360 |
| Responsible Party: | FHI 360 |
| ClinicalTrials.gov Identifier: | NCT01334190 History of Changes |
| Other Study ID Numbers: |
10264 |
| First Posted: | April 13, 2011 Key Record Dates |
| Last Update Posted: | July 2, 2013 |
| Last Verified: | July 2013 |
Keywords provided by FHI 360:
|
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 post-marketing monitoring safety efficacy acceptability |