NCT01684358

Brief Summary

This unblinded, randomized controlled trial (RCT) among women to determine: 1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women who receive a contraceptive implant immediately at baseline during three months of follow up compared to women who receive the implant at the three month follow-up visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

September 10, 2012

Last Update Submit

November 4, 2014

Conditions

Women Wanting Contraceptive Implant for Pregnancy Prevention

Keywords

Prostate-specific antigenContraceptive implantBiological markerCondomsWomen

Outcome Measures

Primary Outcomes (1)

  • Prostate-specific antigen (PSA)

    Number of women with recent exposure to semen as measured by the detection of prostate-specific antigen (PSA) in vaginal swabs

    3 months

Secondary Outcomes (4)

  • Self-reported exposure to semen

    3 months

  • Side effects

    3 months

  • Product discontinuation

    3 months

  • Acceptability

    3 months

Study Arms (2)

Immediate implant

EXPERIMENTAL

Sino-implant (II) inserted at enrollment visit

Device: Sino-implant (II)

Delayed implant

ACTIVE COMPARATOR

Sino-implant (II) inserted at 3-month follow-up visit

Device: Sino-implant (II)

Interventions

Sino-implant (II)DEVICE

Sino-implant (II) (Shanghai Dahua Pharmaceutical Co, Ltd.; Shanghai, China), a contraceptive implant with two rods each of which contain 75 mg of levonorgestrel.

Also known as: Zarin, TRUST, Femplant
Delayed implantImmediate implant

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epidemiology Research Training Unit

Kingston, Kingston, 5, Jamaica

Location

Related Publications (3)

  • Zia Y, Wiener J, Snead MC, Papp J, Phillips C, Flowers L, Medley-Singh N, Costenbader EC, Hylton-Kong T, Kourtis AP. Assessing prevalence of missed laboratory-confirmed sexually transmitted infections among women in Kingston, Jamaica: results from a secondary analysis of the Sino-Implant clinical trial. BMJ Open. 2018 Apr 13;8(4):e019913. doi: 10.1136/bmjopen-2017-019913.

    PMID: 29654017DERIVED

  • Snead MC, Wiener J, Ewumi S, Phillips C, Flowers L, Hylton-Kong T, Medley-Singh N, Legardy-Williams J, Costenbader E, Papp J, Warner L, Black C, Kourtis AP. Prevalence and risk factors associated with STIs among women initiating contraceptive implants in Kingston, Jamaica. Sex Transm Infect. 2017 Nov;93(7):503-507. doi: 10.1136/sextrans-2016-052963. Epub 2017 May 5.

    PMID: 28476913DERIVED

  • Rattray C, Wiener J, Legardy-Williams J, Costenbader E, Pazol K, Medley-Singh N, Snead MC, Steiner MJ, Jamieson DJ, Warner L, Gallo MF, Hylton-Kong T, Kourtis AP. Effects of initiating a contraceptive implant on subsequent condom use: A randomized controlled trial. Contraception. 2015 Dec;92(6):560-6. doi: 10.1016/j.contraception.2015.06.009. Epub 2015 Jun 14.

    PMID: 26079469DERIVED

Study Officials

  • Carole Rattray, DM

    University of West Indies

    STUDY CHAIR

  • Elizabeth Costenbader, PhD

    FHI 360

    PRINCIPAL INVESTIGATOR

  • Athena Kourtis, MD, PhD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 13, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 5, 2014

Record last verified: 2013-04

Locations

JA(1)