Contraceptive Pills for Discontinuing Implants
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Ethinyl Estradiol / Norgestimate Oral Tablet?
Research shows that Ethinyl Estradiol / Norgestimate is highly effective as a contraceptive, with a very low failure rate (Pearl index of 0.25), and it provides reliable cycle control with minimal side effects like breakthrough bleeding. It also has a favorable impact on metabolic health, such as improving cholesterol levels.12345
Is the combination of norgestimate and ethinyl estradiol generally safe for use in humans?
The combination of norgestimate and ethinyl estradiol is generally considered safe for use in humans, with studies showing minimal effects on weight, blood pressure, and metabolism. It has a low incidence of side effects like acne, nausea, or headaches, and is associated with a lower risk of cardiovascular issues compared to other oral contraceptives.12467
How does the drug norgestimate/ethinyl estradiol differ from other contraceptive options?
Norgestimate/ethinyl estradiol is unique because it contains a third-generation progestin, norgestimate, which has minimal androgenic effects (less likely to cause male-like side effects) and a lower impact on metabolism, potentially reducing the risk of cardiovascular issues compared to other oral contraceptives.13789
What is the purpose of this trial?
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
Eligibility Criteria
This trial is for young individuals aged 14 to 22.9 who are using the etonogestrel implant as a contraceptive for the first time. It's not suitable for those with estrogen-related contraindications, plans to move away within a year, or a desire to become pregnant in the next year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard counseling or the COCR intervention, which includes advance provision of combined oral contraceptive pills and a bleeding rescue regimen
Follow-up
Participants are monitored for satisfaction with the contraceptive implant and healthcare interactions related to the implant
Treatment Details
Interventions
- Ethinyl Estradiol / Norgestimate Oral Tablet
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor