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The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: Topical Testosterone Solution (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

This study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)] when previously treated with a topical testosterone gel.

Clinical Details

Official title: The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants Achieving Normal Serum Testosterone Levels

Secondary outcome:

Change From Baseline in Serum Testosterone Levels

Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive

Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Able to read, understand, and provide signed informed consent before starting trial

activities related to this study (including discontinuing testosterone replacement therapy prior to Screening)

- Male participants with a diagnosis of hypogonadism and documented biochemical failure

(total testosterone <300 ng/dL) when treated with the highest dose of a topical testosterone gel tolerated by the participant. Documentation of biochemical failure includes: the name and dose of the topical testosterone gel, a lab report showing a total testosterone level <300 ng/dL while on therapy, or a written chart report stating that there was a clear lack of efficacy, including the participant's serum total testosterone level at the time of failure

- Screening serum total testosterone level of <300 ng/dL (based on the average of 2

morning blood samples taken at least 30 minutes apart) at Screening

- Prostate Specific Antigen (PSA) <4 nanogram per milliliter (ng/mL) at Screening

- If the participant is receiving testosterone replacement therapy and is willing to

discontinue testosterone replacement therapy to enter the study, their screening total testosterone level cannot be checked until at least 14 days after discontinuing topical therapies, or after at least 28 days for participants using short-acting intramuscular (IM) therapies Exclusion Criteria:

- Any previous treatment with testosterone topical solution (LY900011)

- Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious

nodules on digital rectal exam at Screening

- Known or suspected breast cancer or history of breast cancer

- Severe sleep apnea (untreated or unsuccessfully treated) in the opinion of the study

investigator

- Use of long-acting IM testosterone undecanoate in the 6-month period prior to

Screening

- History of the use of an implanted testosterone pellets (Testopel)

- International Prostate Symptom Score (IPSS) total score >19 at Screening

- Hematocrit ≥50% at Screening. For sites located at elevations ≥4500 feet,

participants will be excluded with hematocrit >54% according to investigator discretion. Any participant with a hematocrit >54% at later study visits will be withdrawn from the study

- Significant history of allergy and/or sensitivity to the drug products or excipients,

including any history of sensitivity to testosterone and/or sunscreens

- Dermatologic condition in underarm area that might interfere with testosterone

absorption (for example, eczema) or that could be exacerbated by topical testosterone replacement therapy

- History of luteinizing hormone-releasing hormone (LHRH) antagonist or agonist

treatment in the 6 months prior to Screening

- Exhibit any evidence of congestive heart failure [New York Heart Association (NYHA)

Class 2 or above] within 6 months prior to Screening

- Exhibit evidence of severe renal impairment [creatinine clearance <30 milliliter per

minute (mL/min) as determined by the Cockcroft-Gault formula] at Screening

- Exhibit a history of severe liver disease or clinical evidence of hepatic impairment

at Screening

- Any condition that would interfere with the participant's ability to provide informed

consent, or comply with study instructions, or would place the participant at increased risk, or might confound the interpretation of the study results

- Are investigator site personnel directly affiliated with this study and/or their

immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted

- Are currently enrolled in, or discontinued within the last 30 days from, a clinical

trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Encinitas, California 92024, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Diego, California 92103, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Parker, Colorado 80134, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gainesville, Georgia 30501, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Coeur D' Alene, Idaho 83814, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Anderson, Indiana 46011, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jeffersonville, Indiana 47130, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Billings, Montana 59101, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Elkhorn, Nebraska 68022, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Marlton, New Jersey 08053, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Garden City, New York 11530, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Poughkeepsie, New York 12601, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cary, North Carolina 27518, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Concord, North Carolina 28025, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Salisbury, North Carolina 28144, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Knoxville, Tennessee 37920, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Austin, Texas 78731, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Marshall, Texas 75670, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Round Rock, Texas 78681, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Antonio, Texas 78228, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seattle, Washington 98104, United States

Additional Information

Starting date: July 2013
Last updated: October 21, 2014

Page last updated: August 23, 2015

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