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Male Contraceptive Gel for Birth Control
Study Summary
This trial is testing a potential male contraceptive gel.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing and able to follow the study rules and sign consent forms.I understand the study details, agree to participate, and have signed the consent form.I agree to use effective birth control during the study.You are not known to have problems with fertility.Your body weight is not excessively high for your height (BMI is less than 33 kg/m2).I am a male who hasn't been in a drug trial in the last 30 days.I am a male with no significant health issues found during screening.I haven't used any androgen-based treatments in the last 6 months.I am a male participant.I have been in a stable, monogamous relationship with a female partner for over a year.I am not pregnant, breastfeeding, planning to become pregnant, or have a current alcohol or drug abuse issue.My recent health checks and lab tests show I am in good health.I am a healthy woman aged 18-34, with regular periods, a uterus, and at least one ovary.I am a man in a stable relationship for over a year and have normal reproductive health.I am between 18 and 50 years old.I am a woman using birth control, not pregnant, and can get pregnant by my partner.I am a man aged 18-50, with a BMI under 33, and haven't used androgens in the last 6 months.I am a man who agrees to follow the study rules and sign the consent forms.If you are a male participant with a female partner, you must agree to use an effective form of birth control during the study. This includes the first 7 days after the study ends.
- Group 1: Nestorone (NES) + testosterone (T) combined gel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this investigation open to individuals below the age of 40?
"This experiment stipulates that only individuals aged 18-50 can participate. There are 52 studies for those below the legal age and 394 more suited to elderly patients."
Who is eligible for inclusion in this research endeavor?
"This medical experiment is open to 420 males aged 18 to 50. To be considered eligible, the male participant must agree to use an accepted form of contraception with his female partner (documented in Appendix 11) during suppression and recovery phases; have a BMI < 33 kg/m2; and not suffer from infertility."
What indications is Nestorone + Testosterone Combination Gel primarily being prescribed for?
"Nestorone + Testosterone Combination Gel is typically utilized to assist with vanishing testis syndrome, but can also be beneficial in managing a variety of other medical conditions including breast, puberty and delayed growth complications as well as gonadotrophin releasing hormone deficiency."
Are there still vacancies available for prospective participants in this research trial?
"Affirmative. Clinicaltrials.gov reveals that this research project, which commenced on October 25th 2018, is actively searching for participants. 420 patients need to be accepted across 8 distinct medical centres."
What prior research has been conducted with regards to the pairing of Nestorone and Testosterone Combination Gel?
"The Nestorone + Testosterone Combination Gel was first examined in 2004 by the USC/Norris Comprehensive Cancer Center and Hospital. Currently, there are 195 successfully concluded experiments involving this medication, with 29 ongoing trials that largely take place in Sacramento, California."
Has the Nestorone + Testosterone Combination Gel been officially endorsed by the FDA?
"Our team at Power has assigned Nestorone + Testosterone Combination Gel a safety rating of 2, as the clinical trials to date support its safety despite the lack of efficacy data."
How many medical centers are offering access to this experiment?
"Potential participants can find 8 medical sites offering this study, with notable centres including UC Davis Health in Sacramento, Comprehensive Women's Health Center in Denver and University of Pennsylvania Medical Center in Philadelphia."
To what extent is this medical trial recruiting participants?
"The clinical trial requires 420 individuals complying with the inclusion criteria to partake. Patients may join this research from various locations, like UC Davis Health in Sacramento and Comprehensive Women's Health Center located in Denver."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- UC Davis Health: < 48 hours
Typically responds via
Average response time
- < 2 Days
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