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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01684358 |
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Date of registration:
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10/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica
SIS |
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Scientific title:
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A Randomized Controlled Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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414 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01684358 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Jamaica
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Contacts
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Name:
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Elizabeth Costenbader, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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FHI 360 |
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Name:
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Carole Rattray, DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of West Indies |
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Name:
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Athena Kourtis, MD, PhD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centers for Disease Control and Prevention |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be willing to be randomized to receive the implant at the enrollment visit or in
three months;
- Be 18-44 years of age;
- Not known to be HIV-positive;
- Have a negative pregnancy test at baseline;
- Not currently using an intrauterine device or system, a contraceptive implant, or
injectable contraception;
- Not planning to start use an intrauterine contraceptive device or system or
injectable contraception in the next three months;
- Not have had surgical sterilization or plan to have it in the next three months;
- Not have medical contraindication to implant use, including lactation within first 6
weeks postpartum, acute deep venous thrombosis or pulmonary embolism, lupus, migraine
with aura, unexplained vaginal bleeding, current or history of breast cancer,severe
cirrhosis, liver tumors, history of stroke, and current or history of ischaemic heart
disease;
- Be willing to return to the clinic for two follow-up visits over the next three
months; and
- Be otherwise a good candidate for study participation based on investigator
assessment
Age minimum:
18 Years
Age maximum:
44 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Women Wanting Contraceptive Implant for Pregnancy Prevention
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Intervention(s)
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Device: Sino-implant (II)
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Primary Outcome(s)
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Prostate-specific antigen (PSA)
[Time Frame: 3 months]
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Secondary Outcome(s)
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Acceptability
[Time Frame: 3 months]
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Self-reported exposure to semen
[Time Frame: 3 months]
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Side effects
[Time Frame: 3 months]
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Product discontinuation
[Time Frame: 3 months]
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Secondary ID(s)
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CDC-NCCDPHP-6163
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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