Trial · NCT00702650
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
NCT00702650, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations. Trials, record NCT00702650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00702650
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
- NCT number
- NCT00702650
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Hypogonadism
- Interventions
- Testosterone MD-Lotion
- First posted
- 2008-06-20
- Last updated
- 2011-07-25
- Results first posted
- 2011-01-05
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 | Day 120 | Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL). |
| Secondary | Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL | Day 120 | Cmax is the maximum observed serum concentration (\>1500 ng/dL) during the 24 hour period on Day 120. |
| Secondary | Percentage of Participants With Cmax Between 1800 and 2500 ng/dL | Day 120 | Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120. |
| Secondary | Percentage of Participants With Cmax >2500 ng/dL | Day 120 | Cmax is the maximum observed serum concentration (\>2500 ng/dL) during the 24 hour period on Day 120. |
| Secondary | Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL | Day 120 | Cmin is the minimum observed serum concentration (\<300 ng/dL) during the 24 hour period on Day 120. |
| Secondary | Change From Baseline to Endpoint in Psychosexual Daily Questionnaire | Baseline, Day 120 | Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35). |
| Secondary | Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36) | Baseline, Day 120 | The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). |
| Secondary | Change From Baseline to Endpoint in Fasting Insulin | Baseline, up to Day 120 | |
| Secondary | Change From Baseline to Endpoint in Fasting Glucose | Baseline, up to Day 120 | |
| Secondary | Change From Baseline to Endpoint in Prostate Specific Antigen (PSA) | Baseline, Day 120 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 | Day 120 | All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. Participants were also included if they withdrew prior to Day 120 because of adverse event or lack of efficacy (considered as treatment failures). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL | Day 120 | All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cmax Between 1800 and 2500 ng/dL | Day 120 | All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cmax >2500 ng/dL | Day 120 | All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL | Day 120 | All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in Psychosexual Daily Questionnaire | Baseline, Day 120 | All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36) | Baseline, Day 120 | All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Fasting Insulin | Baseline, up to Day 120 | Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal. | uIU/mL | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Fasting Glucose | Baseline, up to Day 120 | Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal. | mg/dL | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Prostate Specific Antigen (PSA) | Baseline, Day 120 | Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120. | ng/mL | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 | Testosterone MD-Lotion | 84.1 | 95% Confidence Interval 77.95 to 90.17 | percentage of participants | |
| Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL | Testosterone MD-Lotion | 5.2 | percentage of participants | ||
| Percentage of Participants With Cmax Between 1800 and 2500 ng/dL | Testosterone MD-Lotion | 3.0 | percentage of participants | ||
| Percentage of Participants With Cmax >2500 ng/dL | Testosterone MD-Lotion | 0.7 | percentage of participants | ||
| Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL | Testosterone MD-Lotion | 64.4 | percentage of participants | ||
| Change From Baseline to Endpoint in Psychosexual Daily Questionnaire | Testosterone MD-Lotion | Sexual Desire | 1.49 | Standard Deviation 1.84 | units on a scale |
| Change From Baseline to Endpoint in Psychosexual Daily Questionnaire | Testosterone MD-Lotion | Overall Sexual Activity Score | 0.94 | Standard Deviation 1.43 | units on a scale |
| Change From Baseline to Endpoint in Psychosexual Daily Questionnaire | Testosterone MD-Lotion | Erection Maintained for Satisfactory Duration | 1.11 | Standard Deviation 2.0 | units on a scale |
| Change From Baseline to Endpoint in Psychosexual Daily Questionnaire | Testosterone MD-Lotion | Positive Mood | 0.56 | Standard Deviation 1.25 | units on a scale |
| Change From Baseline to Endpoint in Psychosexual Daily Questionnaire | Testosterone MD-Lotion | Negative Mood | -0.50 | Standard Deviation 1.33 | units on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Testosterone MD-Lotion | 155 | |
| Overall Study | COMPLETED | Testosterone MD-Lotion | 135 | |
| Overall Study | NOT COMPLETED | Testosterone MD-Lotion | 20 |
Source ClinicalTrials.gov
Adverse events41
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Testosterone MD-Lotion | 4 | 155 | 4 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Testosterone MD-Lotion | 2 | 155 | 2 |
| other | Nausea | Gastrointestinal disorders | Testosterone MD-Lotion | 2 | 155 | 3 |
| other | Vomiting | Gastrointestinal disorders | Testosterone MD-Lotion | 4 | 155 | 4 |
| other | Application site erythema | General disorders | Testosterone MD-Lotion | 8 | 155 | 9 |
| other | Application site irritation | General disorders | Testosterone MD-Lotion | 11 | 155 | 19 |
| other | Application site oedema | General disorders | Testosterone MD-Lotion | 2 | 155 | 2 |
| other | Application site warmth | General disorders | Testosterone MD-Lotion | 2 | 155 | 4 |
| other | Fatigue | General disorders | Testosterone MD-Lotion | 3 | 155 | 3 |
| other | Pyrexia | General disorders | Testosterone MD-Lotion | 3 | 155 | 3 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Testosterone MD-Lotion | ||
| Total, other adverse events | Testosterone MD-Lotion | 80 | 155 |
| Total, serious adverse events | Testosterone MD-Lotion | 1 | 155 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00702650
GET https://conductscience.org/api/trials/v1/NCT00702650/results?page=2