Testosterone Effects on Pelvic Floor Muscles

NCT04026880 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 2018P000248
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 urodynamic parameters in postmenopausal women with urinary incontinence than that associated with placebo administration

Conditions

Urinary Incontinence; Menopause

Keywords

Androgens; Menopause; Urinary Incontinence; Pelvic Floor Muscles

Outcome Measures

Primary Outcomes (1)

• Change in pelvic floor muscle volume

  Pelvic floor muscle volume will be measured by 3-dimensional dynamic pelvic floor magnetic resonance imaging (MRI)

  12 weeks

Secondary Outcomes (7)

• Change in urine volume at first desire to void

  12 weeks

• Change in urine volume at first urge to void

  12 weeks

• Change in maximum cystometric capacity (when the patient feels she can no longer delay micturition)

  12 weeks

• Change in urine flow

  12 weeks

• Change in urethral sphincter contraction strength

  12 weeks

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

weekly IM administration of 25 mg Testosterone Enanthate for 12 weeks

Drug: Testosterone Enanthate

Control Arm

PLACEBO COMPARATOR

Weekly IM administration of placebo for 12 weeks

Drug: Placebo

Interventions

Testosterone Enanthate DRUG

25 mg testosterone enanthate administered by intramuscular injection weekly for 12 weeks

Also known as: Delatestryl

Treatment Arm

Placebo DRUG

Placebo administered by intramuscular injection weekly for 12 weeks

Also known as: Inactive comparator

Control Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (1)

• Huang G, Basaria S, Travison TG, Ho MH, Davda M, Mazer NA, Miciek R, Knapp PE, Zhang A, Collins L, Ursino M, Appleman E, Dzekov C, Stroh H, Ouellette M, Rundell T, Baby M, Bhatia NN, Khorram O, Friedman T, Storer TW, Bhasin S. Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: effects on sexual function, body composition, muscle performance and physical function in a randomized trial. Menopause. 2014 Jun;21(6):612-23. doi: 10.1097/GME.0000000000000093.

  PMID: 24281237 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Interventions

testosterone enanthate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Grace Huang, MD

  Partners Health Care, Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share