ContraceptionNCT01930994
Kenya Sino-implant (II) PK Study
An observational study of Contraception, run by FHI 360 at 1 site in Kenya.
Trial summary
A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years of used and Jadelle during five years of use by Kenyan women. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 0 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between the ages of 18 and 44 who have received contraceptive implants from the Marie Stopes Kenya Eastleigh clinic and MSK mobile clinics in the Nairobi area.
Who may be able to join
- Have a Sino-implant (II) or Jadelle implant set in place, confirmed by physical exam;
- Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;
- Be aged between 18 and 44 years, inclusive;
- Not wish to become pregnant in the next six months;
- Not desire implant removal within the next six months.
- Be able to understand the information given to them and to make personal decisions on whether to participate or not in the study;
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- Consent to participation, and sign an informed consent form;
- Agree and be able to return to the clinic for the second study visit.
- Exclusion Criteria: The following criteria exclude participation in the study:
- Use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's wort (Hypericum perforatum), by self-report;7
- Use of medications containing LNG or other hormones that impact LNG or SHBG disposition, e.g. treatment with LNG or oral contraceptives for bleeding disturbances, by self-report;
- Use of anti-retroviral drugs, by self-report;
- Any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Study to Compare Sino-implant (II) During Four Years of Use to Jadelle During Five Years of Use by Kenyan Women
A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years of used and Jadelle during five years of use by Kenyan women.
Read the detailed description
A cross-sectional study to compare the pharmacokinetics of Sino-implant (II) during four years of use and Jadelle during five years of use by Kenyan women. The active ingredient in both implants is levonorgestrel (LNG) which is a synthetic progestin that has been used in combined oral contraceptives and in progestin-only pills for more than 30 years.
Population: A total of 280 women between the ages of 18 to 44 years who are currently using Sino-implant (II) or Jadelle contraceptive implants will be enrolled in one of six cohorts of women:
Cohort 1: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 6-month insertion anniversary.
Cohort 2: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 12-month insertion anniversary.
Cohort 3: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 24-month insertion anniversary.
Cohort 4: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 36-month insertion anniversary.
Cohort 5: (n=40 Sino-implant (II), n=40 Jadelle) women enrolled 1-3 months before their 48-month insertion anniversary.
Cohort 6: (n=40 Jadelle) women enrolled 2-6 months before their 60-month insertion anniversary.
Women in all cohorts will be followed for up to 6 months.
Study Duration: Up to 6 months of participant recruitment and up to 6 months elapsed after the baseline visit for the second study visits. 15 months total in the field including training, study initiation, recruitment, follow-up, and close-out.
Two blood samples spaced 2 to 6 months apart will be drawn from each woman for hormone measurements.
Primary Objective: To compare total and free levonorgestrel (LNG) plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at five years of Jadelle use in Kenyan women
Secondary Objectives:
- To compare total and free LNG plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at four years of Jadelle use
- To characterize the total and free LNG plasma concentration-time profiles over four years following Sino-implant (II) and over five years following Jadelle insertion
- To characterize the sex hormone binding globulin (SHBG) serum concentration-time profile over four years following Sino-implant (II) and over five years following Jadelle insertion
- Conditions
- Contraception
- Keywords
- LNG: Levonorgestrel, MSI: Marie Stopes International, MSK: Marie Stopes Kenya, PK: Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Twenty Sino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 6-month insertion anniversary. | |
| Cohort 2 | TwentySino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 12-month insertion anniversary; | |
| Cohort 3 | Twenty Sino-implant (II) and twenty Jadelle) users enrolled 1-3 months before their 24-month insertion anniversary | |
| Cohort 4 | Twenty Sino-implant(II) and twenty Jadelle users enrolled 1-3 months before their 36-month insertion anniversary; | |
| Cohort 5 | Forty Sino-implant (II) and forty Jadelle users enrolled 1-3 months before their 48-month insertion anniversary; | |
| Cohort 6 | Forty Jadelle users enrolled 2-6 months before their 60-month insertion anniversary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years
Total and free LNG plasma concentrations measured at four years of Sino-implant (II)use and at five years of Jadelle use
Measured: 6 months
Secondary outcomes (3)
Total and Free LNG concentrations at Four Years of Jadelle and Sino-implant Use
Total and free LNG plasma concentrations at 4 years of Sino-implant (II) use and total and free LNG plasma concentrations at 4 years of Jadelle use
Measured: 6 months
Total and free LNG plasma concentration-time profiles at 4 years following Sino-implant (II) and at over 5 years following Jadelle insertion
Total and free LNG plasma concentration-time profiles at 4 years of Sino-implant(II)use compared to over 5 years of Jadelle use
Measured: 6 months
SHBG serum concentration-time profile over 4 years following Sino-implant (II) and over 5 years following Jadelle insertion.
SHBG serum concentration-time profile at at 4 years of Sino-implant(II)use compared to over 5 years of Jadelle use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Insufficient numbers of Sino-implant users available for study participation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Marie Stopes International
- Responsible party
- Sponsor
- Investigators
- Mark Ayallo, MD, Principal investigator, Marie Stopes Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930994
- Sponsor's protocol ID
- 475139
- Status last verified
- Oct 2013
- First submitted
- 21 Aug 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study to Compare Sino-implant (II) During Four Years of Use to Jadelle During Five Years of Use by Kenyan Women
- ClinicalTrials.gov ID
- NCT01930994
- Acronym / sponsor ID
- 475139
- Conditions
- Contraception
- Keywords
- LNG: Levonorgestrel, MSI: Marie Stopes International, MSK: Marie Stopes Kenya, PK: Pharmacokinetic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient numbers of Sino-implant users available for study participation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Marie Stopes International
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years of used and Jadelle during five years of use by Kenyan women.
Detailed description
A cross-sectional study to compare the pharmacokinetics of Sino-implant (II) during four years of use and Jadelle during five years of use by Kenyan women. The active ingredient in both implants is levonorgestrel (LNG) which is a synthetic progestin that has been used in combined oral contraceptives and in progestin-only pills for more than 30 years.
Population: A total of 280 women between the ages of 18 to 44 years who are currently using Sino-implant (II) or Jadelle contraceptive implants will be enrolled in one of six cohorts of women:
Cohort 1: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 6-month insertion anniversary.
Cohort 2: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 12-month insertion anniversary.
Cohort 3: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 24-month insertion anniversary.
Cohort 4: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 36-month insertion anniversary.
Cohort 5: (n=40 Sino-implant (II), n=40 Jadelle) women enrolled 1-3 months before their 48-month insertion anniversary.
Cohort 6: (n=40 Jadelle) women enrolled 2-6 months before their 60-month insertion anniversary.
Women in all cohorts will be followed for up to 6 months.
Study Duration: Up to 6 months of participant recruitment and up to 6 months elapsed after the baseline visit for the second study visits. 15 months total in the field including training, study initiation, recruitment, follow-up, and close-out.
Two blood samples spaced 2 to 6 months apart will be drawn from each woman for hormone measurements.
Primary Objective: To compare total and free levonorgestrel (LNG) plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at five years of Jadelle use in Kenyan women
Secondary Objectives:
- To compare total and free LNG plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at four years of Jadelle use
- To characterize the total and free LNG plasma concentration-time profiles over four years following Sino-implant (II) and over five years following Jadelle insertion
- To characterize the sex hormone binding globulin (SHBG) serum concentration-time profile over four years following Sino-implant (II) and over five years following Jadelle insertion
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Twenty Sino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 6-month insertion anniversary. |
| Cohort 2 | – | –TwentySino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 12-month insertion anniversary; |
| Cohort 3 | – | –Twenty Sino-implant (II) and twenty Jadelle) users enrolled 1-3 months before their 24-month insertion anniversary |
| Cohort 4 | – | –Twenty Sino-implant(II) and twenty Jadelle users enrolled 1-3 months before their 36-month insertion anniversary; |
| Cohort 5 | – | –Forty Sino-implant (II) and forty Jadelle users enrolled 1-3 months before their 48-month insertion anniversary; |
| Cohort 6 | – | –Forty Jadelle users enrolled 2-6 months before their 60-month insertion anniversary. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between the ages of 18 and 44 who have received contraceptive implants from the Marie Stopes Kenya Eastleigh clinic and MSK mobile clinics in the Nairobi area.
Key inclusion criteria (13 listed)
- Have a Sino-implant (II) or Jadelle implant set in place, confirmed by physical exam;
- Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;
- Be aged between 18 and 44 years, inclusive;
- Not wish to become pregnant in the next six months;
- Not desire implant removal within the next six months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years
Time frame: 6 months
Total and free LNG plasma concentrations measured at four years of Sino-implant (II)use and at five years of Jadelle use
3 secondary outcomes
Total and Free LNG concentrations at Four Years of Jadelle and Sino-implant Use
Time frame: 6 months
Total and free LNG plasma concentration-time profiles at 4 years following Sino-implant (II) and at over 5 years following Jadelle insertion
Time frame: 6 months
SHBG serum concentration-time profile over 4 years following Sino-implant (II) and over 5 years following Jadelle insertion.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ayallo, MD principal investigator
Marie Stopes Kenya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by FHI 360 at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.