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Contraceptive Effectiveness of Sino-implant (II) in China

Sponsored by FHI 360

About this trial

Last updated 9 years ago

Study ID

458241-1

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
20 to 44 Years
Female
Female

Trial Timing

Ended 9 years ago

What is this trial about?

A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the 3rd and 4th years of use in Chinese women

What are the participation requirements?

Yes

Inclusion Criteria

- Have a confirmed Sino-implant (II) set in place;

- Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;

- Be aged between 20 and 44 years, inclusive;

- Not wish to become pregnant in the next year;

- No desire to get implant removal within the next year;

- Be able to understand the information given to them and to make personal decisions on whether to participate or not in the study;

- Consent to participation and sign an informed consent form;

- Agree and be able to return to the clinic for follow-up visit(s).

No

Exclusion Criteria

- Acute liver disease or cirrhosis by self-report;

- Benign or malignant tumor of the liver by self-report;

- 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;

- Known HIV-positive status 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.