ContraceptionNCT01594632
Safety,Effectiveness and Acceptability of Sino-implant II in DR
A study testing Jadelle and Sino-implant (II) in people with Contraception, run by FHI 360 at 1 site in Dominican Republic.
Trial summary
A study to assess the contraceptive effectiveness of Sino-implant (II). 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
- What is being tested?
- Jadelle and Sino-implant (II)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jan 2011to 4 Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- Aged between 18 and 44 years, inclusive
- Not pregnant
- Not lactating
- Not wishing to become pregnant in the next five years
- Request long-acting reversible contraception
- If previously used injectable contraceptives for pregnancy prevention, be more than 9 months since last injection of Depo-Provera and more than 3 months after the last injection of a combined injectable contraceptive
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- If previously used LNG-containing oral pills or implants, be more than 1 week after last hormone intake or implant removal
- Be able to understand the information provided and to make personal decisions on participation
- Consent to participation and sign a consent form
- Agree and be able to return to the clinic for follow-up visits over five years
Who cannot join
- acute deep venous thrombosis and/or pulmonary embolism or history of thromboembolic disease
- systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
- unexplained vaginal bleeding
- current or history of breast cancer
- acute liver disease or cirrhosis
- benign or malignant tumor of the liver
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- use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's Wort (Hypericum perforatum)
- more than one sexual partner in the last 3 months
- diagnosis or treatment for a sexually transmitted infection (STI) within the past 30 days for her or partner (excluding recurrent genital herpes or condyloma)
- known HIV positive status for her or partner
- 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
- BMI greater than or equal to 30 (for the sub-group of women with intensive LNG sampling)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II
A study to assess the contraceptive effectiveness of Sino-implant (II).
Read the detailed description
Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and Jadelle.
- Conditions
- Contraception
- Being tested
- Jadelle, Sino-implant (II)
- Keywords
- 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 Harmonization, 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JadelleDrug
LNG containing subdermal contraceptive implant
Sino-implant (II)Drug
Also called Zarin, Femplant, Trust, Simplant
LNG containing subdermal contraceptive implant
| Study group | Role | What they receive |
|---|---|---|
| Jadelle | Experimental | Contraception using Jadelle implant Receives: Drug: Jadelle |
| Sino-implant (II) | Active comparator | levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant] Receives: Drug: Sino-implant (II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use.
Pearl Index (number of pregnancies per 100 woman-years) over 4 years of use of Sino-implant (II).
Measured: 4 years
Secondary outcomes (5)
Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use
Pearl Index over 5 years of use of Sino-implant (II) ; continuation \& reasons for discontinuation in both groups.
Measured: 5 years
Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle
annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II);
Measured: 5 years
Compare pharmacokinetic profiles of Sino-implant (II) and Jadelle during the first 6 months of use in a sub-group of users undergoing intensive levonorgestrel sampling
The PK profile of LNG during the first 6 months post-insertion including the following parameters in a sub-group of users undergoing intensive LNG sampling:
Mean LNG concentrations at 6 hours, 24 hours, 48 hours, 72 hours, 7 days and 90 days post-insertion Concentration-time profiles of LNG (individual and pooled) Maximal concentration (Cmax) and time to maximal concentration (Tmax) AUC0-7 days, AUC0-1mon, AUC0-3mon and AUC0-6mon
Measured: 5 years
Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use
Adverse event rates in both treatment groups Annual and cumulative probability of early discontinuation in both treatment groups Reasons for discontinuation in both treatment groups Responses on acceptability questionnaires in both treatment groups
Measured: 5 years
Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users.
free levonorgestrel index, estimated as the ratio of levonorgestrel to sex hormone binding globulin at various point during 5 years of product use in a sub-group of approximately 150 women.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2011
- Primary completion4 Jul 2017
- Study completion4 Jul 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Vivian Brache, LIC, Principal investigator, Profamilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594632
- Sponsor's protocol ID
- 10242
- Status last verified
- Sep 2017
- First submitted
- 13 Oct 2011
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II
- ClinicalTrials.gov ID
- NCT01594632
- Acronym / sponsor ID
- 10242
- Conditions
- Contraception
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jan 2011
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 9 May 2012 (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 study to assess the contraceptive effectiveness of Sino-implant (II).
Detailed description
Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and Jadelle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jadelle | Experimental | Drug: JadelleContraception using Jadelle implant |
| Sino-implant (II) | Active comparator | Drug: Sino-implant (II)levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant] |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged between 18 and 44 years, inclusive
- Not pregnant
- Not lactating
- Not wishing to become pregnant in the next five years
- Request long-acting reversible contraception
Key exclusion criteria (12 listed)
- acute deep venous thrombosis and/or pulmonary embolism or history of thromboembolic disease
- systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
- unexplained vaginal bleeding
- current or history of breast cancer
- acute liver disease or cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JadelleLNG containing subdermal contraceptive implant | Drug | Jadelle |
| Sino-implant (II)Also: Zarin, Femplant, Trust, SimplantLNG containing subdermal contraceptive implant | Drug | Sino-implant (II) |
Primary outcome
Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use.
Time frame: 4 years
Pearl Index (number of pregnancies per 100 woman-years) over 4 years of use of Sino-implant (II).
5 secondary outcomes
Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use
Time frame: 5 years
Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle
Time frame: 5 years
Compare pharmacokinetic profiles of Sino-implant (II) and Jadelle during the first 6 months of use in a sub-group of users undergoing intensive levonorgestrel sampling
Time frame: 5 years
Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use
Time frame: 5 years
Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Vivian Brache, LIC principal investigator
Profamilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jadelle and Sino-implant (II) in people with Contraception, run by FHI 360 at 1 site in Dominican Republic.
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 10 inclusion and 12 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: finished, as of the sponsor's last update on 21 Sep 2017. 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 Dominican Republic. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use. (time frame: 4 years). 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 21 Sep 2017.