Desogestrel and Ethinyl Estradiol Tablets for Contraception

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Colorado Denver, Aurora, CO
Contraception
Desogestrel and Ethinyl Estradiol Tablets - Drug
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a 24-hour trough concentration can be used as a proxy for the area under the curve.

See full description

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Desogestrel and Ethinyl Estradiol Tablets will improve 2 primary outcomes in patients with Contraception. Measurement will happen over the course of 24 hours.

24 hours
Serum ethinyl estradiol concentrations
Serum etonogestrel concentrations

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Overall Cohort
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Desogestrel And Ethinyl Estradiol Tablets 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.

Overall Cohort
Drug
Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 hours for reporting.

Closest Location

University of Colorado Denver - Aurora, CO

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Healthy females aged 18-45 years
Body-mass index ≥18.5kg/m2
Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study
Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg)
Negative urine pregnancy test at screening

Patient Q&A Section

What causes contraception?

"The number of contraception methods does not necessarily reflect the desire for contraception. It is important for health professionals to be [sensitive to the desires of the women to use contraception] and to [provide a framework for dialogue between patient and physician on contraceptives]. Improved contraceptive education in the context of counselling and a shared decision-making model for contraceptive management could help reproductive health professionals." - Anonymous Online Contributor

Unverified Answer

How many people get contraception a year in the United States?

"About 710,000 American women a year receive emergency contraception. This is the largest use of emergency contraception in the United States, representing 12.5% of those eligible to obtain emergency contraception. The number of women eligible to receive emergency contraception far exceeds the number of women in need." - Anonymous Online Contributor

Unverified Answer

What are the signs of contraception?

"Signs of contraception include bleeding, cramping or painful sex and increased frequency of menstrual bleeding. More significant bleeding or discharge is also a sign of pregnancy.\n" - Anonymous Online Contributor

Unverified Answer

Can contraception be cured?

"Sperm counts decrease during the process of spontaneous conception. This decline may be the cause of spontaneous abortion. However, there is also evidence that hormonal changes after ovulation suppress fertility, but the cause of infertility is unknown. The decline of fertility with age is not a permanent decrease. The chance of pregnancy declines to 1% of 35 year olds. In some groups the fertility rate rises with age. As fertility remains a problem into late adolescence and adulthood with hormonal contraception, the process of spontaneous conception may not cease as much as fertility. This is termed a latent fertility rate, which can be improved with the use of fertility-stimulating fertility medicines (such as gonadotrophins)." - Anonymous Online Contributor

Unverified Answer

What is contraception?

"The aim of this article is to provide an updated overview of contraception, which should give a useful guide for the patients who want to find out the best options for them. The various contraceptive methods are divided into birth control methods and fertility contraception methods." - Anonymous Online Contributor

Unverified Answer

What are common treatments for contraception?

"Aspects of contraception, particularly the hormonal birth control methods of the pill and patch appear to have a significant preventive effect against chronic lung disease." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of contraception?

"Among the women surveyed, the primary cause of contraception was the woman's own decision. Some women reported not using a condom because they wanted contraception. The fact that multiple reasons for contraception were reported by respondents, and the high rate of satisfaction with the contraceptive method showed that these methods are not being used for the primary purpose of family planning. However, the high rate of use compared to those not using contraception is good." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of desogestrel and ethinyl estradiol tablets?

"It was proven that desogestrel and ethinyl estradiol tablets do not have any side effects, but it is recommended to check with a doctor and to make sure that you have a thorough medical check-up before the first hormonal contraceptive method is taken orally and after four months of treatment. After four months, it is easy to be sure that it worked. It is easy for pills with a lot of small and big particles to be absorbed quickly by the intestine, and this can be seen in the urine when taking contraceptives." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating contraception?

"The findings of this study showed that there is current interest in creating new treatments to curb the number of pregnancies in women who have difficulty using conventional contraception. The findings were gathered by tracking the number of papers published per country on a yearly basis. Some countries with high rate of publication were: US, Australia, UK, China, and France"" - Anonymous Online Contributor

Unverified Answer

What is desogestrel and ethinyl estradiol tablets?

"DNG, the main active hormone component of DES, was absorbed rapidly from the gastrointestinal tract and its concentration remained higher than its baseline levels throughout the 12-h study period of the single dose study. However, it was observed that the peak and the AUC of estradiol increased with increasing doses of DES, whereas the Cmax did not." - Anonymous Online Contributor

Unverified Answer

How serious can contraception be?

"It is important to consider the risks of the many forms of contraception and the likelihood that all will fail, especially if a person has a history of previous unintended pregnancy. Women who are planning a termination of pregnancy should discuss the risks of contraception with a family planning clinician." - Anonymous Online Contributor

Unverified Answer

What is the latest research for contraception?

"As a group, women are still safer from sexual assaults than men; an increase in the number of women who are using birth control has led to more women being assaulted, according to researchers. Women, but not men, who report no contraceptives are more likely to suffer from STIs; contraception is the most effective way to avoid contracting STIs; and women on combined oral contraceptives are less likely to suffer from STIs. Birth control users (women, but not men) are less likely to have STDs and are less likely to suffer from an STI than non-contraceptive users." - Anonymous Online Contributor

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