Treatment Trials

26 Clinical Trials for Various Conditions

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

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

UNKNOWN
Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015)
Description

This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of Dimethandrolone Undecanoate (DMAU) administered as an intramuscular or subcutaneous injection.

UNKNOWN
Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men
Description

This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to evaluate the spermatogenesis suppression after oral administration of Dimethandrolone Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.

UNKNOWN
28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
Description

This is a Phase I multicenter, double-blind, repeat dose, dose-escalating study, in healthy men to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC).

COMPLETED
Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males
Description

This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.

UNKNOWN
Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
Description

The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.

COMPLETED
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
Description

The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU) as a male hormonal contraceptive. The study has two parts. The first is a dose escalating study in healthy to assess the safety and tolerability of single dose oral administration of DMAUin healthy men.(Completed) The second is to study the safety and tolerability of DMAU after 28 days of repeated daily dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral administration of DMAU.

COMPLETED
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
Description

This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.

Conditions
WITHDRAWN
ITT-5 Mechanisms of Spermatogenesis in Man
Description

The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.

COMPLETED
Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
Description

To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.

Conditions
COMPLETED
HOP-2A - Intratesticular Hormone Levels
Description

The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

COMPLETED
ORAL T-6: Oral Androgens in Man-6
Description

We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

COMPLETED
ACY-7 Oral Administration of Acyline
Description

We propose oral dosing of gastrointestinal permeation enhancement technology \[GIPET\] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.

Conditions
COMPLETED
PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue
Description

The investigators propose to examine the in vivo responses to hormonal manipulation at the molecular level directly in the tissue of interest (prostate). As in the investigators' previous, pilot study, the investigators will use the novel approach of procuring tissue specimens from normal, healthy men who might be chose to use a male hormonal contraceptive regimen were it available. The investigators will employ state of the art techniques such as laser capture microdissection (LCM) and cDNA microarrays to determine the tissue-specific consequences of male hormonal contraceptive regimens on the prostate. The results will help guide the design, safety monitoring, and selection of male hormonal contraceptive agents and provide valuable insights into prostate human prostate biology. The investigators will test the hypothesis that exogenous T administration that results in increased circulating T and dihydrotestosterone (DHT) levels will increase intraprostatic concentrations of T and its metabolite DHT. The investigators will test the hypothesis that the addition of a potent 5α-reductase inhibitor, dutasteride, or the progestin, Depomedoxyprogesterone (IM DMPA), to T administration in young and middle aged men will decrease intraprostatic DHT and increase intraprostatic T concentrations compared to T alone. The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T, by reducing intraprostatic DHT, will decrease prostate epithelial proliferation, assessed by Ki-67 labeling index (Ki-67LI), and increase apoptosis, assessed by caspase-3 expression, and decrease androgen-regulated protein expression such as prostate specific antigen (PSA). The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor or the progestin IM DMPA to exogenous T, by modifying the intraprostatic hormonal milieu, will alter prostate epithelial gene expression. Specifically, the investigators expect that the addition of the 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T, will result in decreased expression of androgen-regulated genes such as PSA.

Conditions
COMPLETED
ACY-6 Oral Administration of Acyline
Description

In this study, we propose oral dosing of GIPET enhanced oral acyline (MER-104) to determine if this potentially useful compound is safe and effective at suppression of gonadotropins after oral dosing in man. Hypothesis: A single dose of Acyline will suppress gonadotropins, and testosterone, estradiol and dihydrotestosterone (DHT) for 24 hours in man, and the magnitude and duration of the suppression will increase with increasing doses of Acyline.

Conditions
COMPLETED
NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel
Description

The purpose of this study is to determine the usefulness of two transdermal gels to be used in the future development for a male contraceptive.

Conditions
COMPLETED
The Effects of Testosterone on Prostate Tissue (ACYP-1)
Description

The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

COMPLETED
Male Hormonal Contraceptive Development-ACY-5
Description

The purpose of this research study is to help in the development of male contraception (birth control).

Conditions
COMPLETED
Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
Description

The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.

COMPLETED
Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum
Description

This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. Participation is voluntary. The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.

Conditions
COMPLETED
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
Description

The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.

Conditions
COMPLETED
A Two-part Trial Assessing the Effects of 7α-methyl-19-nortestosterone (MENT) on Blood Pressure in Normal Men: an Open-label Pilot Study Followed by a Randomized, Double-blind, Placebo-controlled Study
Description

This is a two-part trial assessing the effects of MENT on blood pressure. The first part of the trial is an open-label pilot study to verify the MENT gel formulation delivers appropriate drug levels. Upon confirming MENT serum levels are within the required range, clinical trial material will be produced and labeled. Consequently, the second part of the trial, the main study, will proceed approximately two months after the conclusion of the pilot study. The main study, is a randomized, double-blind, placebo-controlled study.

Conditions
COMPLETED
A Trial of an Adolescent Male Sexual Health Intervention
Description

Early unintended fatherhood and rates of sexually transmitted infections remain national concerns, disproportionately affecting minority, underserved adolescent males, many of whom frequently use emergency departments (EDs) for medical care. EDs must implement effective sexual and reproductive health interventions that are evidence-based and reproducible. This research will conduct pilot testing of a personalized and interactive digital intervention specifically targeting adolescent males entitled Dr. Eric that is theory-based, user-informed, and scalable across EDs.

COMPLETED
Evaluation of Polyurethane Male Condoms
Description

The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.

COMPLETED
Hormonal Contraceptive Health Education for Adolescent Males
Description

Prospective randomized control trial of an educational electronic application on female hormonal contraception for adolescent males in the pediatric emergency department.

COMPLETED
An Evaluation of Virtual Student Health Center Among Incarcerated Juvenile Offenders
Description

WestEd and its partners Efficacity and the Oregon Youth Authority (OYA), are conducting a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U, for youthful male offenders. This study involves male teenagers (age 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The innovative, non-curricular, technology-based intervention, Healthy U, is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. The purpose of this study is to test this intervention on a population of young men incarcerated at the OYA who will soon be released into the community. The intervention is tailored to this population by updating the design, videos, and examples to best reflect the youth in the study, and OYA staff are being trained to facilitate the self-guided intervention.