40 Participants Needed

Testosterone Therapy for Pain in Postmenopausal Women

GH
SB
JC
Overseen ByJulia Crosby
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Must be taking: Opioid analgesics
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, physical function and quality of life when compared with placebo in women with chronic back pain treated with opioids who have low testosterone.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have used testosterone, spironolactone, finasteride, or systemic ketoconazole in the past 3 months.

What evidence supports the effectiveness of testosterone therapy for pain in postmenopausal women?

Research suggests that testosterone therapy can improve symptoms like fatigue, low libido, and overall well-being in postmenopausal women, which may indirectly support its potential to alleviate pain by enhancing quality of life.12345

Is testosterone therapy safe for postmenopausal women?

Studies suggest that testosterone therapy in women, including postmenopausal women, generally has a good safety profile. It has shown favorable effects on cardiovascular health and cognitive performance, with no adverse cardiovascular effects observed in studies of transdermal testosterone therapy. However, more research is needed to fully understand its long-term safety and effects on cancer risk.46789

How does the drug Testosterone Cypionate differ from other treatments for pain in postmenopausal women?

Testosterone Cypionate is unique because it addresses symptoms potentially linked to low testosterone levels, such as fatigue and low libido, which are not typically targeted by standard pain treatments for postmenopausal women. This drug may improve overall well-being by supplementing testosterone, which is often reduced after menopause.12101112

Research Team

SB

Shehzad Basaria, M.D.

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for postmenopausal women over 60 with chronic back pain who have been on opioids for at least 6 months and show low testosterone levels. They must have a normal mammogram, appropriate endometrial thickness, and be able to consent. Women with a history of certain cancers, severe obesity, recent heart issues or strokes, specific blood conditions or kidney dysfunction are not eligible.

Inclusion Criteria

I have long-term back pain not caused by cancer.
Use of opioid analgesics for at least 6 months
Serum total testosterone <8.7 ng/dL and/or free testosterone <0.47 pg/mL
See 4 more

Exclusion Criteria

Baseline hematocrit >48%
I have not had a heart attack, stroke, or any heart surgery in the last 3 months.
Serum creatinine >2.5 mg/dL
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly intramuscular administration of testosterone or placebo for 3 months

12 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Testosterone Cypionate
Trial OverviewThe TRAPP Trial is testing if testosterone replacement (using Testosterone Cypionate) can better improve pain perception, tolerance, sexual function, physical ability and life quality in these women compared to a placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TestosteroneExperimental Treatment1 Intervention
Weekly intramuscular administration at a dose of 3 mg
Group II: PlaceboPlacebo Group1 Intervention
Weekly intramuscular administration of placebo

Testosterone Cypionate is already approved in United States for the following indications:

🇺🇸
Approved in United States as Depo-Testosterone for:
  • Primary hypogonadism
  • Hypogonadotropic hypogonadism
  • Delayed puberty

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

Testosterone replacement therapy can significantly improve symptoms like fatigue and low libido in postmenopausal women experiencing androgen deficiency, enhancing their overall quality of life.
The exact mechanism of how testosterone exerts its therapeutic effects—whether directly or through conversion to estrogen—is still unclear, but the use of testosterone in hormone replacement regimens for women is likely to increase with new formulations becoming available.
Androgen replacement in women: a commentary.Davis, S.[2013]
Short-term testosterone therapy, especially when combined with traditional hormone treatments, has been shown to improve sexual function in postmenopausal women, particularly those with hypoactive sexual desire disorder.
While testosterone therapy shows promise, it may negatively affect lipid profiles, particularly with oral methyltestosterone, and more research is needed to understand its long-term health risks and the specific populations that would benefit most.
Androgen and menopause.Somboonporn, W.[2013]
Testosterone replacement therapy aims to maintain physiological testosterone levels, with parenteral testosterone undecanoate showing significant improvement by providing stable levels for up to 12 weeks, compared to traditional esters that require administration every 2-3 weeks.
Transdermal testosterone gel offers a flexible dosing option and produces stable serum testosterone profiles, making it particularly recommended for elderly males, while allowing for immediate discontinuation in case of complications.
Advances in testosterone replacement therapy.Gooren, L.[2019]

References

Androgen replacement in women: a commentary. [2013]
Androgen and menopause. [2013]
Advances in testosterone replacement therapy. [2019]
Administration of testosterone undecanoate in postmenopausal women: effects on androgens, estradiol, and gonadotrophins. [2019]
Testosterone replacement therapy in the climacteric: benefits beyond sexuality. [2019]
Testosterone in women--the clinical significance. [2022]
Testosterone depot injection in male hypogonadism: a critical appraisal. [2021]
Current options for injectable contraception in the United States. [2013]
Pilot study of home self-administration of subcutaneous depo-medroxyprogesterone acetate for contraception. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The safety of postmenopausal testosterone therapy. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Testosterone therapy in premenopausal women. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Testosterone deficiency in women: etiologies, diagnosis, and emerging treatments. [2013]