Status:
WITHDRAWN
Testosterone Effects on Pelvic Floor Muscles
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Urinary Incontinence
Menopause
Eligibility:
FEMALE
60+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Androgen therapy has been widely promoted in women with low serum testosterone levels for the treatment of sexual dysfunction and also for potentially improving body composition, muscle performance, b...
Eligibility Criteria
Inclusion
- Medically stable, ambulatory, postmenopausal women, 60 years of age or older
- 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.
- Able to give informed consent
- Women with either stress urinary incontinence, or mixed urinary incontinence (stress and urgency)
Exclusion
- Women with endometrial stripe \>4 mm on pelvic ultrasound
- ≥ 1 first-degree relative with breast cancer
- Previous pelvic surgery (ie. hysterectomy)
- Women with history of radiation treatment to the pelvis
- Any neurologic disorder causing urinary incontinence or bladder dysfunction (ie. multiple sclerosis)
- Estrogen therapy currently or in the past 3 months
- Women who have been diagnosed with major psychoses or bipolar disorders and/or untreated depression
- Women with severe depression and/or severe anxiety as measured by the Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI), respectively
- Any acute or subacute illness that required hospitalization in the last three months
- Cancers that require active therapy (not in remission for at least two years) including those with a life expectancy less than 5 years
- Poorly controlled diabetes mellitus (hemoglobin A1c greater than 8.0%). Subjects on insulin therapy will be excluded.
- Uncontrolled hypertension defined as an average of two blood pressure readings of greater than 160/100
- Severe obesity defined as body mass index of greater than 40 kg/m2
- Current or recent (last 6 months) users of illicit drugs
- 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
- History of breast, ovarian, or endometrial cancer.
- 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.
- Significant acne, defined as grade 3 on Palatsi Acne Scale
- 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.
- 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
- 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.
- Undiagnosed vaginal or vulvar bleeding
- Women taking concurrent anticoagulants or how have bleeding disorders
- History of deep vein thrombosis, pulmonary embolism, or other thromboembolic disorder
- Current enrollment in clinical drug intervention studies in the preceding 90 days
- 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)
- Women who have previously experienced intolerance to testosterone enanthate injections
- 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).
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04026880
Start Date
January 1 2021
End Date
June 1 2022
Last Update
July 20 2022
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