CLINICAL TRIAL

Etonogestrel for Contraception

Stage II
Recruiting · Any Age · Female · Albuquerque, NM

This study is evaluating whether an implant placed in the first 24 hours after birth may help breastfeeding.

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About the trial for Contraception

Treatment Groups

This trial involves 2 different treatments. Etonogestrel 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Etonogestrel
DRUG
Nexplanon
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Etonogestrel
DRUG
Nexplanon
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etonogestrel
FDA approved

Eligibility

This trial is for female patients of any age. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Students must have a working phone in order to receive study questions show original
I suggest agreeing to some level of randomization in the study show original
are candidates for the study Pregnant women, women who have delivered vaginally or by cesarean section within the last 22 hours, and women who had an implant inserted within 24 hours of giving birth are all candidates for the study. show original
For persons aged 13 and older. show original
I am planning on breastfeeding. show original
I would like to have an implant as a method of contraception. show original
English or Spanish speakers
The infant should be delivered at UNM Hospital if it is more than 37 weeks gestational age. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: For the primary outcome will be the first eight weeks after delivery.
Screening: ~3 weeks
Treatment: Varies
Reporting: For the primary outcome will be the first eight weeks after delivery.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: For the primary outcome will be the first eight weeks after delivery..
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Etonogestrel will improve 2 primary outcomes and 7 secondary outcomes in patients with Contraception. Measurement will happen over the course of For the primary outcome will be the first eight weeks after delivery..

Continuation of breastfeeding.
FOR THE PRIMARY OUTCOME WILL BE THE FIRST EIGHT WEEKS AFTER DELIVERY.
Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.
FOR THE PRIMARY OUTCOME WILL BE THE FIRST EIGHT WEEKS AFTER DELIVERY.
Time to lactogenesis.
FIRST 7 DAYS.
To compare time to lactogenesis stage II between women in the immediate versus standard group.
FIRST 7 DAYS.
Postpartum mood.
UP TO 24 WEEKS POSTPARTUM.
To compare postpartum mood as measured by Edinburgh Postnatal Depression Scale (EPDS) score at 2, 4, 8, 12 and 24 weeks postpartum. Results reported as a total score ranging from 0-30, no subscale scores. A higher scale represents a worse outcome, ie. is more predictive of a depressive disorder including postpartum depression.
UP TO 24 WEEKS POSTPARTUM.
Satisfaction with postpartum contraception counseling
UP TO 24 WEEKS POSTPARTUM.
Using a questionnaire the investigators seek to compare participant satisfaction with postpartum contraception counseling. This will be assessed by a questionnaire of six questions using a Likert rating scale including poor, fair, good, very good and excellent. T
UP TO 24 WEEKS POSTPARTUM.
Satisfaction with timing of implant insertion: questionnaire
UP TO 24 WEEKS POSTPARTUM.
Using a questionnaire the investigators seek to compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group. This will be assessed by a questionnaire using a four-point Likert scale including very unsatisfied, unsatisfied, satisfied and very satisfied.
UP TO 24 WEEKS POSTPARTUM.
Sexual Function.
UP TO 24 WEEKS POSTPARTUM.
To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score. Minimum score 2, Maximum score 36. Subscales are combined by first totaling the scores for the individual questions in that domain (ex. for Desire, the sum of scores for questions 1 and 2). That total is then multiplied by the factor for that domain, which is listed in the table above. The output is the final score for that domain, and will fall within the minimum and maximum scores listed in the table above. For every domain, a lower score indicates either no sexual activity or negative outcomes in that domain, while a higher score indicates positive outcomes in that domain.
UP TO 24 WEEKS POSTPARTUM.
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Patient Q & A Section

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

Can contraception be cured?

To our knowledge, this is the first study to present evidence that anosmia can be cured with an implant based on the same strategy used to treat vaginismus.

Anonymous Patient Answer

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

Approximately 20 million US women use a form of contraception that can prevent STD each year. As an extra reminder of the importance of ensuring appropriate contraception, the annual number of new pregnancies prevented is 3.6 million. It's important to be aware of disparities in access, use and coverage throughout the country. The most common reasons for not using effective birth control are shame and embarrassment. Prevention strategies also can be tailored to meet an individual's needs including offering a range of methods, providing information and support to help users maintain use or assist in the choice of a long-acting method to promote continuous use. In addition, educating men, family members, employers and school staff on the importance of family planning can increase its availability.

Anonymous Patient Answer

What is contraception?

There are four main types of contraception: natural contraception, non-hormonal contraception, hormonal contraception and sterilization. There are additional methods and devices that are either used mostly or only by non-Western societies, for example, sterilization by tubal ligation in India. All forms of contraception are associated with the prevention of pregnancy, the provision of menstrual cycle health, cervical cancer and protection from sexually transmitted infections. The latter include the prevention of AIDS.

Anonymous Patient Answer

What are the signs of contraception?

While women may be reluctant to discuss contraceptive method choice, they are generally open and willing to do so; however, they may still underestimate their symptoms and concerns about their contraception. For many women, the main concerns about their contraceptive method are pregnancy concerns (especially fear of unwanted pregnancy and fear of unintended pregnancy/previous miscarriage) or infertility concerns (especially fear of infertility and infertility-related issues).

Anonymous Patient Answer

What causes contraception?

The main reasons women need contraception are unsafe sex, unwanted pregnancy, and lack of sexual control. Many of these issues are complicated and are often due to societal pressures and gender inequality. For instance, most of the unsafe sex that leads to pregnancy is due to male behavior and social pressures, including sexual harassment and the risks of STDs, violence, and pregnancy, as well as gender-based assumptions over the male and female roles in intercourse.

Anonymous Patient Answer

What are common treatments for contraception?

The use of hormonal contraceptives has increased, whereas the use of intrauterine devices and sterilization has declined during the past decade in Norway. Both oral contraceptives and intrauterine devices are equally used. The use of the contraceptive patch is increasing. The use of barrier methods has declined, despite the fact that condoms have come to be a method of choice for men. The use of condoms is not an option for men, regardless of ethnicity or sexual orientation.

Anonymous Patient Answer

How serious can contraception be?

Although recent studies are suggesting that some contraceptive methods are not quite as dangerous as previously believed, the vast number of contraceptive users are not at risk of significant medical harm. In the USA, the contraceptive pills and patch have the highest number of emergency department visits for contraceptive-related side effects in women of reproductive age (3-6 million). We recommend that women be reminded that, in fact, these contraceptive devices do carry a very important risk: pregnancy.

Anonymous Patient Answer

What does etonogestrel usually treat?

The prescription of etonogestrel depends significantly on the prescribing physician's interpretation of the patient's age, number of previous pregnancies, and previous hormonal therapy. Etonogestrel is probably not a contraceptive medication. It is not recommended as a single agent for a first cycle of in vitro fertilization. It is recommended as an alternative to intrauterine devices to postpone first conception. It is used in combination with the use of progestins other than progesterone to treat or prevent ovulatory disturbances in patients with polycystic ovary syndrome.

Anonymous Patient Answer

What is the average age someone gets contraception?

The average age someone uses contraception is between 16–18. In general, women are using contraceptive pills for the longer time of their life than men are. This can be a good thing since that keeps people from having babies too early or too late in their life. However, people with health issues or medical conditions are using contraceptives less because they need the contraceptives to help manage those condition. [Figures from UNFPA]].

Anonymous Patient Answer

Has etonogestrel proven to be more effective than a placebo?

Etonogestrel is not more effective than a placebo when used as part of combined birth control pills in the prevention of implantation and gestation defects.

Anonymous Patient Answer

How does etonogestrel work?

Most patients consider etonogestrel to be highly effective and reliable, and most see no limitation to using it without an IUD. Etonogestrel is highly effective as contraception. Most patients also see no limitation to using it without IUD.

Anonymous Patient Answer

Is etonogestrel typically used in combination with any other treatments?

Results from a recent clinical trial has shown that Etonogestrel is mostly used in combination with other contraceptive agents. A combination containing etonogestrel and a progestogen with or without an levonorgestrel component has been shown to be well tolerated and effective with no clinically relevant adverse effects reported.

Anonymous Patient Answer
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