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Ethinyl Estradiol / Norgestimate Oral Tablet for Contraceptive Behavior

Phase 4
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months post-insertion
Awards & highlights

Study Summary

This trial will compare how often people stop using the etonogestrel implant when they are given COCs in advance and a rescue bleeding regimen, compared to standard counseling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months post-insertion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months post-insertion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implant Continuation
Secondary outcome measures
Satisfaction with contraceptive implant
Other outcome measures
Implant-related health care interactions

Trial Design

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 Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,148,926 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research have open enrollment currently?

"Evident from the information on clinicaltrials.gov, this scientific investigation is still searching for participants to enroll. Initially posted on June 18th 2021, the trial was most recently altered on August 17th 2021."

Answered by AI

What is the current threshold for patient enrollment in this trial?

"Affirmative. According to the current information on clinicaltrials.gov, this research is presently seeking participants who were initially advertised for recruitment on June 18th 2021 and updated last August 17th 2021. There are 600 individuals needed at a single site."

Answered by AI

What therapeutic functions does Ethinyl Estradiol / Norgestimate Oral Tablet generally serve?

"Ethinyl Estradiol / Norgestimate Oral Tablet is a well-known medication for treating polycystic ovary syndrome. Additionally, it has been employed to tackle premenstrual dysphoric disorder, severe menopausal vulvovaginal atrophy, and contraception related issues."

Answered by AI

Who meets the eligibility criteria to partake in this research study?

"This medical study is actively seeking 600 teenage and young adult participants who were born prematurely. Participants must be aged between 14 to 22.9 years old, with no prior experience of the etonogestrel implant in order to qualify for recruitment."

Answered by AI

Does this research project include participants aged sixty or higher?

"Per the prerequisites for this clinical trial, only those between 14 and 23 years of age can qualify. The database also features 195 studies explicitly targeting minors and 78 research trials that are open to seniors over 65."

Answered by AI

Are there documented investigations related to Ethinyl Estradiol / Norgestimate Oral Tablet?

"At present, there are 11 active medical trials for Ethinyl Estradiol / Norgestimate Oral Tablet with 2 Phase 3 studies. Multiple cities across the US including Savannah, Georgia offer clinical trial options to patients hoping to utilize this medication."

Answered by AI

What possible risks could be associated with the use of Ethinyl Estradiol / Norgestimate Oral Tablet?

"Data points to a high level of safety associated with Ethinyl Estradiol / Norgestimate Oral Tablet, thus our team at Power assigned it the highest rating on their scale. This treatment is approved for use as part of Phase 4 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Premature Discontinuation of Contraceptive Implants
2021. "Premature Discontinuation of Contraceptive Implants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04828824.
~157 spots leftby Apr 2025
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