Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075855
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2004-01-09
Brief Title:
Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors A Phase III Randomized Placebo-Controlled Double-Blind Crossover Study
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE The hormone testosterone may improve the libido sex drive in women It is not yet known whether testosterone is effective in improving libido in female cancer survivors
PURPOSE This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors
PURPOSE This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of low-dose testosterone in terms of average intra-patient change in libido in postmenopausal female cancer survivors with a decreased libido
Secondary
Determine the toxic effects of this drug in these patients
Determine the levels of estrogen and testosterone and SGOT in patients reporting a decreased libido before and after treatment with this drug
Determine whether increasing libido significantly positively affects pleasure from sexual activity in patients treated with this drug
Determine the effect of this drug on vitality general quality of life and overall mood in these patients
OUTLINE This is a double-blind placebo-controlled randomized crossover multicenter study Patients are stratified according to antidepressant medication use yes vs no age under 50 vs 50 to 60 vs 61 to 70 vs over 70 tamoxifen or other selective estrogen receptor modulator use yes vs no and ovarian status in place natural menopause or hysterectomy vs not in place bilateral oophorectomy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive topical testosterone once daily for 4 weeks
Arm II Patients receive a topical placebo once daily for 4 weeks After 4 weeks patients cross over to the other treatment arm
Changes in sexual functioning mood states and medical outcome vitality are assessed at baseline and then at the end of weeks 4 and 8
Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months
Primary
Determine the efficacy of low-dose testosterone in terms of average intra-patient change in libido in postmenopausal female cancer survivors with a decreased libido
Secondary
Determine the toxic effects of this drug in these patients
Determine the levels of estrogen and testosterone and SGOT in patients reporting a decreased libido before and after treatment with this drug
Determine whether increasing libido significantly positively affects pleasure from sexual activity in patients treated with this drug
Determine the effect of this drug on vitality general quality of life and overall mood in these patients
OUTLINE This is a double-blind placebo-controlled randomized crossover multicenter study Patients are stratified according to antidepressant medication use yes vs no age under 50 vs 50 to 60 vs 61 to 70 vs over 70 tamoxifen or other selective estrogen receptor modulator use yes vs no and ovarian status in place natural menopause or hysterectomy vs not in place bilateral oophorectomy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive topical testosterone once daily for 4 weeks
Arm II Patients receive a topical placebo once daily for 4 weeks After 4 weeks patients cross over to the other treatment arm
Changes in sexual functioning mood states and medical outcome vitality are assessed at baseline and then at the end of weeks 4 and 8
Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000349426 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02568 | REGISTRY | None | None |