Urinary IncontinencePhase 3TPELVICNCT04026880
Testosterone Effects on Pelvic Floor Muscles
A Phase 3 study testing Testosterone Enanthate in people with Urinary Incontinence and Menopause, run by Brigham and Women's Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Menopause
- What is being tested?
- Testosterone Enanthate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 28Show fewer
- 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).
About this study
Official title: A Pilot Study To Evaluate The Effect of Testosterone Enanthate On Structural and Functional Characteristics of Pelvic Floor Muscles In Postmenopausal Women With Urinary Incontinence
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
Read the 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, bone mineral density and cognition. Androgens are known to exert direct anabolic effects on skeletal muscle. Testosterone supplementation results in dose-dependent increases in both muscle mass and strength in men. Similarly, our group has also demonstrated that 24-weeks of testosterone administration in hysterectomized women with low testosterone levels was associated with dose and concentration-dependent gains in lean body mass, chest-press power and loaded stair-climb power. Given that androgen receptors have been shown to be expressed throughout the pelvic floor and lower urinary tract, the anabolic effects of androgens on pelvic floor muscles and urethral sphincter may provide a therapeutic option in women with urinary incontinence.
In spite of the recognition of the important role of androgens in regulation of pelvic floor muscle mass and function, no randomized trials of the effects of testosterone or selective androgen receptor modulators have been published. Towards our long-term goal of conducting such a randomized efficacy trial of the effect of androgens in women with urinary incontinence, this initial pilot study will provide important data as a proof-of-the concept that the mass and function of levator ani and other pelvic floor muscles can be increased meaningfully by administration of testosterone, and that the increase in the mass and function of pelvic floor muscles will be associated with significant improvements in urodynamic parameters. Although MRI has been used clinically to evaluate pelvic floor anatomy, dynamic MRI of the pelvic floor muscles coupled with urodynamic studies has not been standardized previously; an important aim of this pilot study is to optimize the procedures for dynamic MR imaging of the pelvic floor structures and couple them with evaluation of urodynamics of the urinary bladder, bladder sphincter, and the urethra. Furthermore, the preliminary estimates of effect size and variance generated in this pilot study will guide the estimates of sample size and statistical power in subsequent larger randomized efficacy trials of androgens in women with urinary incontinence.
- Conditions
- Urinary Incontinence, Menopause
- Being tested
- Testosterone Enanthate, Placebo
- Keywords
- Androgens, Menopause, Urinary Incontinence, Pelvic Floor Muscles
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone EnanthateDrug
Also called Delatestryl
25 mg testosterone enanthate administered by intramuscular injection weekly for 12 weeks
PlaceboDrug
Also called Inactive comparator
Placebo administered by intramuscular injection weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | weekly IM administration of 25 mg Testosterone Enanthate for 12 weeks Receives: Drug: Testosterone Enanthate |
| Control Arm | Placebo comparator | Weekly IM administration of placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pelvic floor muscle volume
Pelvic floor muscle volume will be measured by 3-dimensional dynamic pelvic floor magnetic resonance imaging (MRI)
Measured: 12 weeks
Secondary outcomes (7)
Change in urine volume at first desire to void
Urine volume at first desire to void will be assessed by cystometry
Measured: 12 weeks
Change in urine volume at first urge to void
Urine volume at first urge to void will be assessed by cystometry
Measured: 12 weeks
Change in maximum cystometric capacity (when the patient feels she can no longer delay micturition)
Maximum Cystometric Capacity will be assessed by cystometry
Measured: 12 weeks
Change in urine flow
Rate of urine flow (urine volume voided over time) will be assessed by Uroflowmetry
Measured: 12 weeks
Change in urethral sphincter contraction strength
Strength of urethral sphincter contraction will be assessed by urethral pressure profilometry.
Measured: 12 weeks
Change in urine leak point pressure
Urine leak point pressure will be assessed by cystometry
Measured: 12 weeks
Change in self-reported urinary incontinence
Urinary Incontinence will be assessed by the Urogenital Distress Inventory (UDI-6 Short Form). The UDI-6 Short Form is a questionnaire with 6 questions that assess the presence and severity of urinary incontinence symptoms. Each question has a potential score of 1 to 4. The final UDI-6 score is calculated by adding all scores as explained above, and dividing the result by 6 to obtain a mean value which is in turn multiplied by 25 to obtain the scale score.
The total scaled score can range from 0 to 100, higher scores indicating more severe urinary incontinence, and lower scores indicating less severe urinary incontinence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Huang, Brigham and Women's Hospital
- Investigators
- Grace Huang, MD, Principal investigator, Partners Health Care, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026880
- Sponsor's protocol ID
- 2018P000248
- Acronym
- TPELVIC
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24281237
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study To Evaluate The Effect of Testosterone Enanthate On Structural and Functional Characteristics of Pelvic Floor Muscles In Postmenopausal Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04026880
- Acronym / sponsor ID
- TPELVIC / 2018P000248
- Conditions
- Urinary Incontinence, Menopause
- Keywords
- Androgens, Menopause, Urinary Incontinence, Pelvic Floor Muscles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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, bone mineral density and cognition. Androgens are known to exert direct anabolic effects on skeletal muscle. Testosterone supplementation results in dose-dependent increases in both muscle mass and strength in men. Similarly, our group has also demonstrated that 24-weeks of testosterone administration in hysterectomized women with low testosterone levels was associated with dose and concentration-dependent gains in lean body mass, chest-press power and loaded stair-climb power. Given that androgen receptors have been shown to be expressed throughout the pelvic floor and lower urinary tract, the anabolic effects of androgens on pelvic floor muscles and urethral sphincter may provide a therapeutic option in women with urinary incontinence.
In spite of the recognition of the important role of androgens in regulation of pelvic floor muscle mass and function, no randomized trials of the effects of testosterone or selective androgen receptor modulators have been published. Towards our long-term goal of conducting such a randomized efficacy trial of the effect of androgens in women with urinary incontinence, this initial pilot study will provide important data as a proof-of-the concept that the mass and function of levator ani and other pelvic floor muscles can be increased meaningfully by administration of testosterone, and that the increase in the mass and function of pelvic floor muscles will be associated with significant improvements in urodynamic parameters. Although MRI has been used clinically to evaluate pelvic floor anatomy, dynamic MRI of the pelvic floor muscles coupled with urodynamic studies has not been standardized previously; an important aim of this pilot study is to optimize the procedures for dynamic MR imaging of the pelvic floor structures and couple them with evaluation of urodynamics of the urinary bladder, bladder sphincter, and the urethra. Furthermore, the preliminary estimates of effect size and variance generated in this pilot study will guide the estimates of sample size and statistical power in subsequent larger randomized efficacy trials of androgens in women with urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: Testosterone Enanthateweekly IM administration of 25 mg Testosterone Enanthate for 12 weeks |
| Control Arm | Placebo comparator | Drug: PlaceboWeekly IM administration of placebo for 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone EnanthateAlso: Delatestryl25 mg testosterone enanthate administered by intramuscular injection weekly for 12 weeks | Drug | Treatment Arm |
| PlaceboAlso: Inactive comparatorPlacebo administered by intramuscular injection weekly for 12 weeks | Drug | Control Arm |
Primary outcome
Change in pelvic floor muscle volume
Time frame: 12 weeks
Pelvic floor muscle volume will be measured by 3-dimensional dynamic pelvic floor magnetic resonance imaging (MRI)
7 secondary outcomes
Change in urine volume at first desire to void
Time frame: 12 weeks
Change in urine volume at first urge to void
Time frame: 12 weeks
Change in maximum cystometric capacity (when the patient feels she can no longer delay micturition)
Time frame: 12 weeks
Change in urine flow
Time frame: 12 weeks
Change in urethral sphincter contraction strength
Time frame: 12 weeks
Change in urine leak point pressure
Time frame: 12 weeks
Change in self-reported urinary incontinence
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 24281237Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Huang, MD principal investigator
Partners Health Care, Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone Enanthate in people with Urinary Incontinence and Menopause, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic floor muscle volume (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.