600 Participants Needed

Contraceptive Pills for Discontinuing Implants

EG
JS
Overseen ByJeanelle Sheeder, PhD
Age: < 65
Sex: Female
Trial Phase: Phase 4
Sponsor: University of Colorado, Denver
Must be taking: Etonogestrel implant
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

You are between ages of 14 to 22.9 years
Started etonogestrel implant for the first time and have never used the implant before

Exclusion Criteria

There is any contraindication to estrogen containing birth control
Plans to move from the area in next 12 months and is not able to come to the clinic
You plan to become pregnant within the next year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard counseling or the COCR intervention, which includes advance provision of combined oral contraceptive pills and a bleeding rescue regimen

12 months
Regular follow-ups as needed

Follow-up

Participants are monitored for satisfaction with the contraceptive implant and healthcare interactions related to the implant

12 months
3 visits (in-person) at 3, 6, and 12 months

Treatment Details

Interventions

  • Ethinyl Estradiol / Norgestimate Oral Tablet
Trial Overview The study tests if giving out combined oral contraceptive pills (COCs) and a bleeding rescue regimen alongside standard counseling reduces premature discontinuation of contraceptive implants compared to just counseling alone.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: COCR ArmExperimental Treatment1 Intervention
Participants in the COCR arm will receive three packs of combined oral contraceptive pills (35mcg ethinyl estradiol/norgestimate) and a specific protocol for their use for bothersome bleeding.
Group II: SOC ArmActive Control1 Intervention
Participants in the SC arm will be offered care according to our standardized protocol, which may include STI testing, reassurance and monitoring, prescription of COCs if desired, or removal.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Findings from Research

Norgestimate/ethinyl estradiol, a new oral contraceptive, shows excellent contraceptive efficacy with a Pearl index of 0.25, indicating a very low failure rate.
This contraceptive has a low impact on carbohydrate and lipid metabolism and does not significantly affect blood coagulation factors, suggesting a potentially lower risk of cardiovascular disease compared to other oral contraceptives, although caution is advised for patients with a history of vascular or thrombotic disorders.
Norgestimate: a clinical overview of a new progestin.Bringer, J.[2019]
Both monophasic and triphasic formulations of ethinyl estradiol plus norgestimate have been shown to provide effective contraception, with efficacy comparable to other oral contraceptives, based on numerous clinical studies.
Both formulations demonstrated favorable metabolic effects, such as increasing good cholesterol (HDL) and reducing the LDL/HDL ratio, while showing minimal impact on weight gain, blood pressure, and carbohydrate metabolism.
Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate.Corson, SL.[2019]
In a study involving 19 healthy women, raltegravir did not significantly affect the pharmacokinetics of the estrogen and progestin components of the oral contraceptive norgestimate-ethinyl estradiol, indicating that it can be safely co-administered without requiring dose adjustments.
The study found that co-administration of raltegravir and the contraceptive was well tolerated, with no serious adverse effects reported, suggesting a favorable safety profile for this combination in HIV-infected patients.
Effect of raltegravir on estradiol and norgestimate plasma pharmacokinetics following oral contraceptive administration in healthy women.Anderson, MS., Hanley, WD., Moreau, AR., et al.[2021]

References

Norgestimate: a clinical overview of a new progestin. [2019]
Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate. [2019]
Effect of raltegravir on estradiol and norgestimate plasma pharmacokinetics following oral contraceptive administration in healthy women. [2021]
Efficacy, cycle control, and safety of two triphasic oral contraceptives: Cyclessa (desogestrel/ethinyl estradiol) and ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol): a randomized clinical trial. [2019]
Pharmacokinetics of oral contraceptive steroids in Egyptian women: studies with Ovral, Nordette and Norminest. [2019]
A norgestimate-containing oral contraceptive: review of clinical studies. [2019]
The efficacy and tolerability of norgestimate/ethinyl estradiol (250 micrograms of norgestimate/35 micrograms of ethinyl estradiol): results of an open, multicenter study of 59,701 women. [2022]
Pharmacokinetic overview of Ortho Evra/Evra. [2019]
A comparative clinical trial of Norinyl 1/35 versus Brevicon in Rio Clara, Brazil. [2019]
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