20 Nov NES-T
This clinical trial is an experimental research study using a potential new form of birth control for men who want to avoid a pregnancy with their sexual partner.
The study product is a combination hormone gel containing Nestorone and Testosterone for men to apply on their upper arms on a daily basis for one-year.
The purpose of this study is to find out:
1) How effective the study gel is at preventing pregnancy in the women when the study gel is applied daily by the male partner for a period of 51-weeks.
2. How safe the study gel is for the male partner to use every day
3. Whether the study gel affects the female or male partner’s everyday life and if it causes any side effects for either partner that are different from those experienced with other forms of contraception.
Men who join the study with their partner should be 18-50 years of age
Women who join the study with their partner should be 18-34 years of age.
Nestorone is a hormone that has been used in research studies to suppress (hold back) ovulation (the release of eggs) in females. In this study, we are using Nestorone and Testosterone Combination Gel to see if it will block the production of male hormones needed to make sperm in men.
Male Partner – Inclusion Criteria: Men who meet all the following criteria will be
eligible for enrollment in the trial:
1. Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;
2. 18 to 50 years of age, at the enrollment visit;
3. BMI < 33 kg/m2;
4. No history of androgen use in the six months prior to the first screening visit;
5. Agreement to use an effective method of contraception with his female partner during the suppression and recovery phases and then only use the experimental method during the efficacy phase of the study;
6. 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;
7. No known infertility;
8. Normal reproductive state as demonstrated by: Sperm concentration ≥15 million/mL in two semen samples: no abnormalities of sperm motility/morphology on one semen sample, Screening Testosterone within the study site’s local lab normal reference range for adult men;
9. Willingness to accept a low but unknown risk of conceiving a pregnancy
for the duration of the trial.
Male Partner – Exclusion Criteria: Men who meet any of the following criteria are
not eligible for enrollment in the trial:
1. 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.
2. Men not living in the catchment’s area of the study site or within a reasonable distance from the site.
3. Clinically significant abnormal findings at screening per the Investigator’s
4. PSA levels ≥ 4 ng/mL.
5. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction.
6. Use of androgens or other anabolic steroids that may suppress
gonadotropins within 6 months prior to the first screening visit.
7. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥
135 mm Hg;
8. History of hypertension, including hypertension controlled with treatment.
9. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
10. Known hypersensitivity to progestins or testosterone or any excipient of
the investigational product.
11. History of prostate, testicular or breast carcinoma.
12. Significant prostatic symptoms (IPSS > 15).
13. Known history of reproductive dysfunction including vasectomy or infertility.
14. Known history of significant cardiac, renal, hepatic or prostatic disease.
15. History of thromboembolic disease.
16. A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment) or HIV.
17. Current active or ongoing hepatitis infection.
18. History of untreated sleep apnea.
19. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use
20. Any skin condition that might interfere with absorption of gel.
21. Couples desiring fertility within the study participation period
(approximately 104 weeks from screening to end of recovery).
22. PHQ9 score ≥15 or history of severe depression or other serious mental health disorder, including ongoing use of an anti-depressant.
Female Partner – Inclusion Criteria: Women who meet all the following criteria will be eligible for enrollment in the trial:
1. Good general health with no chronic medical conditions that result in periodic exacerbations which require significant medical care or are known to affect fertility;
2. Aged between 18 and 34 years, inclusive, at the enrollment visit;
3. 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:
a. If recently used intramuscular Depo-Provera, must have had last injection at least 3 months prior enrollment;
b. 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;
c. 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;
4. Have intact uterus and at least one ovary;
5. Consistent use of effective contraception during the preceding cycle prior to enrolling;
6. No known infertility;
7. 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);
8. Be at risk for pregnancy with participating male partner (heterosexual vaginal intercourse at least once per cycle and not sterilized);
9. Have a negative pregnancy test at enrollment;
Female Partner – Exclusion Criteria:
1. Desire to become pregnant during the study.
3. Known or suspected current alcoholism or drug abuse.
4. Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
5. Currently pregnant.
6. Known hypersensitivity to progestins or testosterone.
7. Previous participation in this clinical trial.
8. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
(206) 616-0484 x_____
Additional Study Details
Full Study Title
Clinical Evaluation of Daily Nestorone (NES) and Testosterone (T) Combination Gel for Male Contraception
Stephanie Page, MD
John Amory, MD
WIlliam J Bremner, MD
Bradley Anawalt, MD
Arthi Thirumalai, MD
Accepts Healthy Volunteers?
University of Washington
1959 NE Pacific Street HSB, Rm C209
Seattle, Washington 98195