The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) - Full Text View

Purpose

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.

Condition	Intervention	Phase
Secondary Hypogonadism	Drug: Androxal (enclomiphene citrate) Drug: Testosterone	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment
Official Title:	A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men

Resource links provided by NLM:

Drug Information available for: Clomiphene citrate Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Clomifene

U.S. FDA Resources

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:

24 Hour Average and Maximum Testosterone Concentration [ Time Frame: Baseline and Week 6 ]
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.

Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.

Secondary Outcome Measures:

Change in Leuteinizing Hormone (LH) [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]
Changes in morning LH after continuous dosing
Change in Follicle Stimulating Hormone (FSH) [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]
Changes in morning FSH after continuous dosing

Other Outcome Measures:

Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. [ Time Frame: Week 6 ]
The Cmax for plasma concentration.
Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. [ Time Frame: Week 6 ]
The Tmax for plasma concentration.
Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. [ Time Frame: Week 6 ]
The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).


Enrollment:	60
Study Start Date:	June 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Androxal 6.25 mg Androxal 6.25 mg/day	Drug: Androxal (enclomiphene citrate) capsule oral 1X a day 6 weeks Other Names: Androxal low testosterone therapy
Experimental: Androxal 12.5 mg Androxal 12.5 mg/day	Drug: Androxal (enclomiphene citrate) capsule oral 1X a day 6 weeks Other Names: Androxal low testosterone therapy
Experimental: Androxal 25 mg Androxal 25 mg/day	Drug: Androxal (enclomiphene citrate) capsule oral 1X a day 6 weeks Other Names: Androxal low testosterone therapy
Active Comparator: AndroGel AndroGel 5G topical testosterone	Drug: Testosterone topical gel 1X a day 6 weeks Other Names: topical testosterone testosterone gel exogenous testosterone

Detailed Description:

Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent
Agreement to use a condom, and with a fertile female partner, another form of contraception.
Agreement to provide a semen sample in the clinic

Exclusion Criteria:

Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
Use of Clomid in the past year or during the study
Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
Clinically significant abnormal findings on screening examination
Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
Known hypersensitivity to Clomid
Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
History of breast cancer
History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA >3.6
History of known hyperprolactinemia with or without a tumor
Chronic use of medications use such as glucocorticoids
Chronic use of narcotics
Subjects known to be positive for HIV
Subjects with end stage renal disease
Subjects with cystic fibrosis (mutation of the CFTR gene)
Subjects unable to provide a semen sample in the clinic
Subject has a BMI >42 kg/m2

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386606

Locations


United States, Texas
Centex Research
Houston, Texas, United States, 77062
Cetero Research
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators


Principal Investigator:	Jolene Berg, MD	Cetero Research, San Antonio

More Information

Additional Information:

Sponsor website This link exits the ClinicalTrials.gov site


Responsible Party:	Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT01386606 History of Changes
Other Study ID Numbers:	ZA-204
Study First Received:	June 29, 2011
Results First Received:	June 13, 2014
Last Updated:	August 21, 2015

Additional relevant MeSH terms:


Neoplasm Metastasis Hypogonadism Neoplastic Processes Neoplasms Pathologic Processes Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Enclomiphene Clomiphene Zuclomiphene	Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents Estrogen Antagonists Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on September 21, 2017