Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    420
  • sponsor
    Health Decisions
Updated on 24 March 2022
depo-provera
hormonal contraception
regular menstrual cycles
testosterone
nestorone
male contraception
Accepts healthy volunteers

Summary

The long term objective is to develop a gel to be used as a male contraceptive.

Description

This is a prospective, phase IIb, open label, single arm, multicenter study. The study protocol consists of a screening phase lasting 4 to 8 weeks, a suppression phase estimated up to 20 weeks, a 52-week maintenance/efficacy phase, and a 24-week (estimated) recovery phase.

The study will involve approximately 420 couples recruited throughout the CCTN that meet eligibility criteria. The fifteen sites propose to enroll up to 420 couples (about 30 to 60 couples per site) with a goal of obtaining 200 couples completing the contraceptive efficacy phase of the study. The study has four phases (screening phase, suppression phase, efficacy phase and recovery phase) with monthly visits to provide the male participants with the NES-8/T-62 gel, to encourage adherence, to monitor for possible side effects, and to quantify semen parameters. The female will be contacted monthly and come in for a visit every three months.

Details
Condition Healthy, Men, Male Contraception
Treatment Nestorone + Testosterone Combination Gel
Clinical Study IdentifierNCT03452111
SponsorHealth Decisions
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men who meet all the following criteria will be eligible for enrollment in the
trial
Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening
18 to 50 years of age, at the enrollment visit
BMI < 33 kg/m2
No history of androgen use in the six months prior to the first screening visit
Agreement to use an effective method of contraception with his female partner (refer to Appendix 11 for acceptable forms of contraception) during the suppression and the first 7 days of the recovery phase and then only use the experimental method during the efficacy phase of the study
In the opinion of the investigator, the male subject is willing and able to comply with the protocol, understand and sign an informed consent and HIPAA form
The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions and has duly signed the informed consent form (ICF)
Sexually active with a female partner (as specified below) with whom he has been in a stable, mutually monogamous relationship for at least 1 year prior to screening and with whom he intends to remain in a relationship for the duration of the study
Normal reproductive state as demonstrated by
Screening Testosterone within the study site's local lab normal reference range for adult men
Sperm concentration ≥15 million/mL in two semen samples and with no gross abnormalities of sperm motility and morphology on at least one semen sample assessment
Willingness to accept a low but unknown risk of conceiving a pregnancy for the
Female participant - Inclusion Criteria
Women who meet all the following criteria will be eligible for enrollment in
duration of the trial
the trial
Good general health with no chronic medical conditions that result in periodic exacerbations which require significant medical care or are known to affect fertility
Aged between 18 and 34 years, inclusive, at the enrollment visit
Have regular menstrual cycles of 21-35 days in duration, per patient report, when not using hormonal contraception. If hormonal contraception has been used, the following
applies
If recently used intramuscular Depo-Provera must have had last injection at least 3 months prior enrollment
If using an IUD or an implant, she is planning to have this removed for purposes unrelated to enrollment in the study prior to entering the efficacy phase
Completion of her last pack of oral contraceptives or completion of effectiveness period for a monthly injection, patch or ring if any has been used prior to entering the efficacy phase
The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions and has duly signed the informed consent form (ICF)
Consistent use of effective contraception during the preceding cycle prior to enrolling
Have intact uterus and at least one ovary
No known infertility
Intends to remain in a monogamous relationship with male study partner (as specified above). (Note: this study will not provide her contraception for intercourse with any other male partners)
Be at risk for pregnancy with participating male partner (heterosexual vaginal intercourse at least once per cycle and not sterilized)
No known infertility
Have a negative pregnancy test at enrollment
Willingness to accept a low but unknown risk of pregnancy and able to understand the need for follow-up in case of pregnancy
No medical contraindication to pregnancy

Exclusion Criteria

Men who meet any of the following criteria are not eligible for enrollment in
the trial
Men participating in another clinical trial involving an investigational drug within the last 30 days (or within five half-lives of the investigational drug, whichever is longer) prior to the first screening visit
Men not living in the catchment's area of the study site or within a reasonable distance from the site
Clinically significant abnormal findings at screening per the Investigator's medical judgment
Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction
Use of androgens or other anabolic steroids that may suppress gonadotropins within 6 months prior to the first screening visit
Elevated PSA levels ≥ 4 ng/mL
History of hypertension, including hypertension controlled with treatment
Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 2 measurements will be used to determine eligibility)
Known hypersensitivity to progestins or testosterone or any excipient of the investigational product
History of prostate, testicular or breast carcinoma
Significant prostatic symptoms (IPSS > 15)
Known history of reproductive dysfunction including vasectomy or infertility
Known history of significant cardiac, renal, hepatic or prostatic disease
History of thromboembolic disease
Current active or ongoing Hepatitis infection
A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV/AIDS
History of untreated sleep apnea
Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance
Any skin condition that might interfere with absorption of gel
Couples desiring fertility within the study participation period (approximately 104 weeks from screening to end of recovery)
Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) of a single application
PHQ9 score ≥10, a score ≥1 on Question #9 on the PHQ9, or history of severe depression or other serious mental health disorder, including ongoing use of an anti-depressant
Use of sex steroids or medications which might interfere with steroid metabolism (i.e., ketoconazole, finasteride, oral corticosteroids, dutasteride, and statins)
Use of anticoagulants
Use of medications that will interfere or interact with Nestorone or Testosterone
Use of oily cosmetic skin gels/products that would prevent absorption of steroids
Previous participation in this clinical trial
Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
Female participant - Exclusion Criteria
Desire to become pregnant during the study
Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
Breastfeeding
Known or suspected current alcoholism or drug abuse
Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit
Currently pregnant
Known hypersensitivity to progestins or testosterone
Previous participation in this clinical trial
Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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