Completed

The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study

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What is being tested

therapeutic testosterone

+ placebo
Drug
Other
Who is being recruted

See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 3
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleThe Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study 
NCT00075855
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
150 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

DISEASE CHARACTERISTICS: * History of cancer * No active disease * Currently has a sexual partner * Reports a decrease in sexual desire or libido and would like an intervention for it * Defined as a score of less than 8 on the numerical analogue scale PATIENT CHARACTERISTICS: Age * See Menopausal status Sex * Female Menopausal status * Postmenopausal, defined as the following: * Surgically induced menopause OR absence of a period for at least 12 months (naturally or treatment-induced) Performance status * ECOG 0-1 Hematopoietic * WBC ≥ 2,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * No untreated anemia Hepatic * SGOT ≤ 1.5 times upper limit of normal (ULN) * No known liver disease Renal * Creatinine ≤ 1.5 times ULN * No renal dysfunction Cardiovascular * No coronary artery disease * No congestive heart failure Other * No untreated hypothyroidism * No diabetes * No major depressive disorder requiring treatment PRIOR CONCURRENT THERAPY: Chemotherapy * Concurrent cytotoxic chemotherapy (e.g., tamoxifen or aromatase inhibitors) allowed Endocrine therapy * No prior testosterone * No prior androgen agents for libido * Concurrent selective estrogen receptor modulators allowed * Concurrent vaginal estrogen allowed provided it was initiated ≥ 1 month ago and continued at the same dose during study participation Radiotherapy * Concurrent radiotherapy allowed Surgery * No prior major pelvic surgery resulting in anatomical changes to the vaginal anatomy * Prior hysterectomy allowed Other * Concurrent antidepressants for postmenopausal mood or hot flashes allowed provided patient is on a stable dose that will not change within the next 8 weeks * No concurrent anticoagulants or propanolol * Concurrent anticoagulants for central or peripheral line maintenance (e.g., warfarin 1 mg daily or heparin flushes) allowed * No other concurrent treatment for decreased libido


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive topical testosterone 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.

Group 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 Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 16 locations
Suspended
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, United StatesSee the location
Suspended
Mayo Clinic - JacksonvilleJacksonville, United States
Suspended
CCOP - Carle Cancer CenterUrbana, United States
Suspended
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, United States

Completed16 Study Centers
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