Testosterone cypionate for Hypogonadism

1
Effectiveness
2
Safety
Brigham and Women's Hospital, Boston, MA
Hypogonadism+4 More
Testosterone cypionate - Drug
Eligibility
18+
Male
Eligible conditions
Hypogonadism

Study Summary

This study is evaluating whether testosterone replacement may help improve pain perception, pain tolerance, sexual function, fatigue, and quality of life for men with chronic back pain who are taking opioids.

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Eligible Conditions

  • Hypogonadism
  • Eunuchism
  • Pain
  • Opioids Use
  • Testicular Hypogonadism

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Testosterone cypionate will improve 2 primary outcomes, 11 secondary outcomes, and 15 other outcomes in patients with Hypogonadism. Measurement will happen over the course of Baseline and 6 months.

6 months
Catastrophizing assessed with the Pain Catastrophizing Scale (PCS) questionnaire
Depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)
Energy, assessed with the Hypogonadism Energy Diary (HED)
Fatigue assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire
Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
Quality of life assessed using the 36-Item Short-Form Survey (SF-36)
Sexual function, assessed with the Sexual Arousal, Interest, and Drive (SAID) questionnaire
Baseline and 6 months
Changes in Patient's Global Impression of Change (PGIC) scores
Changes in default mode network connectivity
Month 6
Changes in catastrophizing assessed with the Pain Catastrophizing Scale (PCS) questionnaire
Changes in depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)
Changes in energy, assessed with the Hypogonadism Energy Diary (HED)
Changes in fatigue assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire
Changes in mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
Changes in quality of life assessed using the 36-Item Short-Form Survey (SF-36)
Changes in response to quantitative sensory testing of pain under a mechanical stimulus
Changes in response to quantitative sensory testing of pain under cold stimulus
Changes in response to quantitative sensory testing of pain under deep pressure stimulus
Changes in response to quantitative sensory testing of pain under heat stimulus
Changes in response to quantitative sensory testing of pain under pressure stimulus
Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
Changes in sexual function, assessed with the Sexual Arousal, Interest, and Drive (SAID) questionnaire
Quantitative sensory testing of pain under a mechanical stimulus
Quantitative sensory testing of pain under cold stimulus
Quantitative sensory testing of pain under deep pressure stimulus
Quantitative sensory testing of pain under heat stimulus
Quantitative sensory testing of pain under pressure stimulus

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo
Testosterone
Placebo group

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Testosterone Cypionate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

TestosteroneIntramuscular injections of testosterone undecanoate 750 mg.
Placebo
Drug
Intramuscular injections of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 3 months, and 6 months for reporting.

Who is running the study

Principal Investigator
S. B. M.
Prof. Shehzad Basaria M.D., Professor of Medicine, Harvard Medical School; Associate Director, Section on Men's Health, Aging & Metabolism, Brigham and Women's Hospital
Brigham and Women's Hospital

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Use of opioid analgesics for at least 6 months.
Serum total testosterone (measured by mass spectrometry) <348 ng/dL and/or free testosterone <70 pg/mL.
Ability and willingness to provide informed consent.
Men, age 18 years and older.
Chronic non-cancer back pain.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been other clinical trials involving testosterone cypionate?

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These 3 trials are important because all of them found testosterone to be as effective as or even more effective than oral testosterone when given in combination with a GnRH stimulation dose. It remains to be determined whether or not there are other [drug treatment trials for testosterone to be able to prove its effectiveness.

Unverified Answer

What are common treatments for hypogonadism?

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The most common treatments for hypogonadism are hormonal contraceptives and/or estrogen-containing oral contraceptive pills that are taken on a regular basis or, in some cases, continuously for a prolonged period of time. In contrast, testosterone or nonhormonal treatments are typically used only temporarily as short-term remedies. This latter group is the most common treatment for hypogonadism across all age groups.

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Can hypogonadism be cured?

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There is low response to estrogen therapy for patients with congenital hypogonadism. Long-term treatment in adulthood is still needed to achieve and maintain optimal hormonal production.

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What is hypogonadism?

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As the ageing epidemic accelerates, men will increasingly have difficulty in achieving optimal physical performance. Reduced circulating testosterone might be one of the contributing factors to this performance decline in middle age. A higher prevalence of hypogonadism was reported among middle-aged and older males living in less affluent countries than well-nourished counterparts.

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What causes hypogonadism?

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Normal gonadal function and libido are necessary for a man's sexual functioning. Failure of these two functions leads to hypogonadism. In other words, the lack of proper androgen action causes the lack of libido and the lack of sexual functioning.

Unverified Answer

What are the signs of hypogonadism?

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Hormonal dysfunction should be suspected in hypoestrogenism when a female patient has hypoestrogenic symptoms in response to low or high dosages of the gonadal hormone replacement therapy. Furthermore, the signs of hypoestrogenism are usually mild and may go unnoticed, particularly at very low dosages of estrogen replacement. However, when hypoestrogenism is seen in the female subjects without other symptoms suggestive of hypoestrogenism, it is not always due to malfunction of the hypothalamic/pituitary gonadal axis.

Unverified Answer

How many people get hypogonadism a year in the United States?

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Approximately 14.5 million US men and women received an IUD from 1992 to 1999. There were 37,040,702 pregnancies among US live births in 1999, which resulted in 12,982 children with a congenital anomaly. Approximately 2,880 will be diagnosed with hypogonadism and 1,650 with delayed puberty.

Unverified Answer

What is testosterone cypionate?

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Testosterone cypionate should be avoided by women using oral contraceptives due to the increase in body triglycerides. The risk of insulin-resistant diabetes with testosteonecypionate is less than that with testosterone. However, further studies are needed to confirm the effectiveness and side effects of testosterone cypionate.

Unverified Answer

How does testosterone cypionate work?

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Testosterone cypionate has no direct or indirect antimineralocorticoid effects in man in doses up to a maximum of 1000 mg/kg sc a week . The testosterone levels, though suppressed, remain within the normal physiologic range and, therefore, do not cause hypergonadotropic hypogonadism. On the other hand, in addition to an increase in endogenous testosterone levels, testosterone is metabolized by its cypionate conjugate (i.e., testosterone cypionate) to the active testosterone form.

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Does hypogonadism run in families?

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These data suggest that the familial pattern of ED is not primarily a consequence of familial inheritance of a predisposing gene, but rather represents a disorder of sex development and is the result of environmental influences affecting both sexes at differing ages.

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Is testosterone cypionate typically used in combination with any other treatments?

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Most of the participants had testosterone cypionate injected only once or twice during the 12-week treatment period and no additional treatment during the follow-up period. The use of other hormonal and nonhormonal treatments were relatively small. This is a reasonable argument against the use of testosterone cypionate in combination with other treatments. We found limited information on a number of the individual treatment options for which combination treatments were used. We did not feel that more information for any of these options would alter our conclusion.

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How serious can hypogonadism be?

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The most severe forms of hypogonadism are rare and usually observed in those who suffer from severe infection; however, low testosterone levels are also considered a symptom of Cushing's syndrome which can lead to Cushingoid appearance and is considered a medical emergency. Milder forms of hypogonadism occur commonly in adolescence, especially males. These include low T levels in some obese males who have never experienced low T levels. Low levels can also be a presentation in some forms of sexual abuse during childhood. Therefore, patients should be familiar with this symptom in clinical presentations. Patients need to avoid drugs that can lower T levels, for example the antiandrogen bicalutamide.

Unverified Answer
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