Testosterone Effects on Pelvic Floor Muscles

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

An proof-of-concept study to determine whether administration of testosterone enanthate weekly results in greater improvements in structural and functional characteristics of pelvic floor muscles and urodynamic parameters in postmenopausal women with urinary incontinence than that associated with placebo administration

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

1. Medically stable, ambulatory, postmenopausal women, 60 years of age or older

2. A normal mammogram in the preceding 12 months of study entry will be required. Women will be asked to either provide documentation of their last mammogram results or, with their permission, sign a medical release form to allow us to obtain the results of their last mammogram.

3. Able to give informed consent

4. Women with either stress urinary incontinence, or mixed urinary incontinence (stress and urgency)

Exclusion Criteria:

1. Women with endometrial stripe >4 mm on pelvic ultrasound

2. ≥ 1 first-degree relative with breast cancer

3. Previous pelvic surgery (ie. hysterectomy)

4. Women with history of radiation treatment to the pelvis

5. Any neurologic disorder causing urinary incontinence or bladder dysfunction (ie. multiple sclerosis)

6. Estrogen therapy currently or in the past 3 months

7. Women who have been diagnosed with major psychoses or bipolar disorders and/or untreated depression

8. Women with severe depression and/or severe anxiety as measured by the Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI), respectively

9. Any acute or subacute illness that required hospitalization in the last three months

10. Cancers that require active therapy (not in remission for at least two years) including those with a life expectancy less than 5 years

11. Poorly controlled diabetes mellitus (hemoglobin A1c greater than 8.0%). Subjects on insulin therapy will be excluded.

12. Uncontrolled hypertension defined as an average of two blood pressure readings of greater than 160/100

13. Severe obesity defined as body mass index of greater than 40 kg/m2

14. Current or recent (last 6 months) users of illicit drugs

15. Significant liver function abnormalities, defined as SGOT, SGPT or alkaline phosphatase value of greater than 1.5 times the upper limit of normal or serum bilirubin levels of greater than 1.5 mg/dl will be excluded

16. History of breast, ovarian, or endometrial cancer.

17. History of hyperandrogenic disorders such as moderate to severe hirsutism and/or acne (by self-report), and polycystic ovary disease. Testosterone administration to these patients may exacerbate the underlying disorder.

18. Significant acne, defined as grade 3 on Palatsi Acne Scale

19. Women with a mammogram that requires follow-up every 3-6 months, or those who have any first-degree relatives with breast cancer will be excluded.

20. Women with history of a major cardiovascular event, including angina, congestive heart failure, cerebral vascular accident or history of myocardial infarction or coronary artery angioplasty or bypass surgery

21. Other Medications. Women who have received in the preceding three months drugs known to affect testosterone production or metabolism such as ketoconazole, Megace, anabolic/androgenic steroids for 3 weeks or longer will be excluded. Women taking ≥ 7.5 mg of prednisone or equivalent glucocorticoid dosing will be excluded. We will also exclude women who are taking or have taken in the past three months medications that affect sexual function (e.g., spironolactone, GnRH agonists). Women receiving thyroid hormone replacement therapy may participate in the study if they have been on a stable replacement dose of L-thyroxine for at least six months.

22. Undiagnosed vaginal or vulvar bleeding

23. Women taking concurrent anticoagulants or how have bleeding disorders

24. History of deep vein thrombosis, pulmonary embolism, or other thromboembolic disorder

25. Current enrollment in clinical drug intervention studies in the preceding 90 days

26. Hematocrit < 30% or >48% (Since hematocrit values can transiently increase as a result of dehydration, and the subjects in this trial are required to come after an overnight fast, hematocrit levels may be repeated once if the investigators determine that the initial elevated hematocrit was influenced by dehydration)

27. Women who have previously experienced intolerance to testosterone enanthate injections

28. Unable to undergo MRI of the pelvis (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes).