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Cancer SurvivorPhase 3NCT00075855

Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors

A Phase 3 study testing therapeutic testosterone in people with Cancer Survivor and Sexual Dysfunction, run by Alliance for Clinical Trials in Oncology at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
therapeutic testosterone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
16 sitesUnited States
Study dates
Apr 2004to Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Medcenter One Health System

    Bismarck, North Dakota, 58501-5505

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
therapeutic testosterone, placebo
Keywords
sexual dysfunction, unspecified adult solid tumor, protocol specific, sexuality and reproductive issues, cancer survivor
Medical subject headings
Sexual Dysfunction, Physiological, Sexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • therapeutic testosteroneDrug

  • placeboOther

Study groups in NCT00075855
Study groupRoleWhat they receive
testosteroneExperimentalPatients 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.
Receives: Drug: therapeutic testosterone
placeboOtherPatients 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.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall mood

    Measured: Up to 6 months

Secondary outcomes (2)

  1. quality of life

    Measured: Up to 6 months

  2. overall vitality

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionMay 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075855
Sponsor's protocol ID
NCCTG-N02C3
Other IDs
NCI-2012-02568, CDR0000349426
Status last verified
Jul 2016
First submitted
9 Jan 2004
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Jones B, Haughie S. Re: randomized controlled trial to evaluate transdermal testosterone in female cancer survivors with decreased libido: north central cancer treatment group protocol N02C3. J Natl Cancer Inst. 2008 Oct 15;100(20):1482; author reply 1482. doi: 10.1093/jnci/djn311. Epub 2008 Oct 7. No abstract available.

    PubMed 18840823

  • Barton DL, Wender DB, Sloan JA, Dalton RJ, Balcueva EP, Atherton PJ, Bernath AM Jr, DeKrey WL, Larson T, Bearden JD 3rd, Carpenter PC, Loprinzi CL. Randomized controlled trial to evaluate transdermal testosterone in female cancer survivors with decreased libido; North Central Cancer Treatment Group protocol N02C3. J Natl Cancer Inst. 2007 May 2;99(9):672-9. doi: 10.1093/jnci/djk149.

    PubMed 17470735

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing therapeutic testosterone in people with Cancer Survivor and Sexual Dysfunction, run by Alliance for Clinical Trials in Oncology at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall mood (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00075855, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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