Ethinyl Estradiol / Norgestimate Oral Tablet for Premature Birth

Phase-Based Estimates
3
Effectiveness
3
Safety
Children's Hospital Colorado, Aurora, CO
Premature Birth+1 More
Ethinyl Estradiol / Norgestimate Oral Tablet - Drug
Eligibility
< 65
Female
Eligible conditions
Premature Birth

Study Summary

Premature Discontinuation of Contraceptive Implants

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Eligible Conditions

  • Premature Birth
  • Contraception Behavior

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Ethinyl Estradiol / Norgestimate Oral Tablet will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Premature Birth. Measurement will happen over the course of within 12 months of insertion.

12 months post-insertion
Implant Continuation
Month 12
Satisfaction with contraceptive implant
Month 12
Implant-related health care interactions

Trial Safety

Trial Design

2 Treatment Groups

Control
COCR Arm

This trial requires 600 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ethinyl Estradiol / Norgestimate Oral Tablet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

COCR Arm
Drug
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, and 12 months post-insertion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3, 6, and 12 months post-insertion for reporting.

Closest Location

Children's Hospital Colorado - Aurora, CO

Eligibility Criteria

This trial is for female patients aged 65 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are between ages of 14 to 22.9 years.
Started etonogestrel implant for the first time and have never used the implant before.

Patient Q&A Section

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

What are common treatments for premature birth?

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The common treatments for premature birth are delivery, phototherapy and antibiotics. Delivery is the treatment of choice for most forms of premature birth and is often effective in improving a mother's ability to care for her newborn. Phototherapy is most often used in the treatment of premature infants who have a high risk of infection. Use of antibiotics to prevent disease in premature infants appears to be important for the prevention of sepsis and bronchopulmonary dysplasia but does not appear to prevent any other form of infection.

Unverified Answer

What is premature birth?

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Premature birth can cause many different health problems in a child, including disabilities, decreased birth weight, developmental delays, and mental stress. Complications can occur at any time before or during a child’s life. The following are just some of the problems that occur.\n

Unverified Answer

Can premature birth be cured?

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Premature birth was only moderately linked with childhood intelligence tests, suggesting that the relationship is unlikely to be causal in the general population. However, the magnitude of any link between premature birth and intelligence may be substantially different in more disadvantaged groups, for example, in ethnic minority groups.

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What are the signs of premature birth?

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The signs of premature birth may be difficult to observe in young babies, but often they are readily visible in babies older than 14 days. Most will require medical investigation to verify the diagnosis of premature birth, to decide on the course of action to be taken, and to start in-depth and ongoing monitoring.\n

Unverified Answer

How many people get premature birth a year in the United States?

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Around 1 in 20 people are born prematurely every year in the United States. Premature birth has a significantly higher risk than the general population of mortality and morbidity.

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What causes premature birth?

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Approximately 20% of births are very premature – under 32 weeks’ gestational age – with increased risks for death and complications for the baby as it is more likely they will be born before their lungs and immune system are fully formed. Maternal factors may also play a role.

Unverified Answer

How serious can premature birth be?

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Premature birth has not been evaluated systematically in all settings. It most commonly occurs between 25 and 29 weeks of gestation and is an important risk factor in perinatal death and morbidity. Therefore, early delivery of premature fetuses is recommended.

Unverified Answer

Is ethinyl estradiol / norgestimate oral tablet typically used in combination with any other treatments?

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A total of 14.5% of females who received the combined oral contraceptive preparations used in the United States were reported as taking ethinyl estradiol/norgestimate, which is higher than the 4.3% of women who took ethinyl estradiol plus either norethisterone acetate or levonorgestrel or in combination with estradiol valerate/progestins before initiation of the combined oral contraceptive pill. The combination of estradiol (E2) plus norgestimate, and/or estrone/norethisterone (E3 + N), appears to be the most commonly used combination.

Unverified Answer

How does ethinyl estradiol / norgestimate oral tablet work?

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This trial failed to demonstrate efficacy when used at low dosage, but there may be a dosage-response relationship. Further studies are needed before this product is recommended for use in any other populations.

Unverified Answer

Does ethinyl estradiol / norgestimate oral tablet improve quality of life for those with premature birth?

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EE/NGM oral tablet is well tolerated at a daily dosage of 2 mg and improves selfreported quality of life in women with PBI, providing a potential complementary, effective, well-tolerated therapy for this group.

Unverified Answer

What are the latest developments in ethinyl estradiol / norgestimate oral tablet for therapeutic use?

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Results from a recent clinical trial show the latest developments in EE/NG oral tablets and vaginal rings in the treatment of patients with anovulatory disorders. There were no reports of the new applications of the vaginal rings.

Unverified Answer

Have there been other clinical trials involving ethinyl estradiol / norgestimate oral tablet?

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There is a substantial body of evidence which suggests the safety and efficacy of the norgestimate / ethinyl estradiol fixed-dose combination for use in all categories of contraception or for relief of postpartum menses. A significant amount of research has also been conducted regarding the efficacy, safety, and tolerability of this product compared with other combined oral contraceptives available in our environment. For a full assessment, it is necessary to review the totality of evidence. The authors do feel that there can be no doubt that this combination has been successfully used in all the indications for which it is licensed. There is an absence of any evidence which is relevant to the safety and efficacy of the combination compared with other preparations of equivalent efficacy.

Unverified Answer
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