PanhypopituitarismPhase 4NCT00144391
Testosterone Gel Applied to Women With Pituitary Gland Problems
A Phase 4 study testing Transdermal Testosterone gel in people with Panhypopituitarism, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Panhypopituitarism
- What is being tested?
- Transdermal Testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age 18-55
- Hypopituitarism with central adrenal and/or gonadal deficiencies. To qualify patients will need to have either 1 or 2 and they need to have 3:
- To diagnose central adrenal deficiency, patients not on glucocorticoid replacement will have an insulin tolerance test (ITT) (patients with cardiovascular disease will be excluded) in which 0.1U/kg of insulin will be given by iv and a peak cortisol value of less than 20ug/dl, associated with a glucose level of less than 40mg/dL will be considered consistent with central adrenal insufficiency. Patients on glucocorticoid replacement will be evaluated by examining their prior workup and if it is determined that they had evidence of central adrenal deficiency, an ITT will not be required to document central adrenal deficiency (an ITT will still be performed to determine GH deficiency).
- To diagnose central gonadal deficiency, patients will be asked if they had amenorrhea or oligomenorrhea prior to estrogen replacement. An FAH of less than 5 MIU/ML will be used to confirm that they have central and not primary gonadal deficiency. In select patients in which the diagnosis of central gonadal deficiency is unclear, we may perform an LHRH stimulation test, in which 100 ug iv of LHRH (Factrel) will be given and a peak LH response of less than 15 MIU/ML will be considered consistent with central gonadotropin insufficiency.
- Serum testosterone level on transdermal estrogen replacement of less than 20 ng/dL or free testosterone of less than 1.5 pg/ml.
- No other significant medical condition
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- Weight between 80 and 150% of ideal body weight
- Able to provide informed consent
- All races and ethnicities
- All patients regardless of marital status and relationship status.
Who cannot join
- Physical disabilities that would prevent them from participating in the study.
- Current use of testosterone or other androgenic steroids. Patients who are taking testosterone, DHEA or other androgen precursors will discontinue these medications/supplements three months prior to the study.
- Significant cardiopulmonary disease (prior myocardial infarction causing ventricular dysfunction, angina, arrhythmias, congestive heart failure, valvular problem), venous thrombotic event (pulmonary embolism or deep vein thrombosis), renal disease (creatinine greater than 1.5 mg/dL), diabetes mellitus on insulin, uncontrolled hypertension, malignancy (other than basal cell skin carcinoma) or major psychiatric disease. Patients with depression or anxiety on a stable dose of medication will be allowed to enroll.
- Current abuse of illicit drugs or heavy ethanol use.
- History of breast cancer or abnormal mammogram at entry. If patients with an abnormal mammogram or PAP smear are appropriately evaluated and found not to have cancer, they will be allowed to participate in the study.
- Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline phosphatase value of greater than one and one-half the upper limit of normal in our Clinical Pathology Laboratory or serum bilirubin levels of greater than 2 mg/dL will be excluded.
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- Those with history of hyperandrogenic disorders such as hirsutism and polycystic ovary disease will be excluded. These conditions are rare in women with hypopituitarism. Testosterone administration to these patients may exacerbate the underlying disorder.
- Women who are pregnant, seeking to become pregnant in the next 6 months, or breast-feeding.
- Those who have previously experienced intolerance to other transdermal systems or gels
- Drugs known to alter testosterone production such as megace or ketoconazole.
- Patients with untreated hyperprolactinemia or active Cushing's disease. Patients with treated prolactinoma or Cushing's disease will be allowed to participate in the study.
- Hematocrit of greater than 50%
- Male sex
- Not willing to answer all questions on surveys
- EKG showing ischemia or prior myocardial infarction
- Patients with extensive brain surgery, severe head injury, brain tumors or other conditions that profoundly affect CNS function.
- Patients not willing to be placed on a standardized hormonal replacement regimen including transdermal estrogen and growth hormone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: Physiologic Testosterone Replacement in Women With Hypopituitarism
The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.
Read the detailed description
Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. Testosterone is commercially available as a hormone replacement therapy for males with an absence or lack of testosterone production. Testosterone for males is mainly given in the form of shots or skin patches which have certain disadvantages such as pain from shots and skin rashes from patches. It is anticipated that this experimental gel application will produce levels of the drug in the normal range in women.
- Conditions
- Panhypopituitarism
- Being tested
- Transdermal Testosterone gel
- Medical subject headings
- Combined Pituitary Hormone Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Testosterone gelDrug
2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Testosterone Gel | Experimental | Transdermal Testosterone Gel (2 mg per pump), 2 pumps per day for 6 months Receives: Drug: Transdermal Testosterone gel |
| Placebo | Placebo comparator | Placebo 2 pumps per day for 6 months Receives: Drug: Transdermal Testosterone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Impact Scale
change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PanhypopituitarismStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Testosterone and Placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Theodore Friedman, Charles Drew University of Medicine and Science
- Investigators
- Theodore C Friedman, M.D., Ph.D., Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144391
- Sponsor's protocol ID
- 03-02-511-07
- Other IDs
- 1U54HD041748-01
- Status last verified
- Apr 2017
- First submitted
- 1 Sep 2005
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Testosterone Replacement in Women With Hypopituitarism
- ClinicalTrials.gov ID
- NCT00144391
- Acronym / sponsor ID
- 03-02-511-07
- Conditions
- Panhypopituitarism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.
Detailed description
Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. Testosterone is commercially available as a hormone replacement therapy for males with an absence or lack of testosterone production. Testosterone for males is mainly given in the form of shots or skin patches which have certain disadvantages such as pain from shots and skin rashes from patches. It is anticipated that this experimental gel application will produce levels of the drug in the normal range in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Testosterone and Placebo
| Arm | Type | Receives |
|---|---|---|
| Transdermal Testosterone Gel | Experimental | Drug: Transdermal Testosterone gelTransdermal Testosterone Gel (2 mg per pump), 2 pumps per day for 6 months |
| Placebo | Placebo comparator | Drug: Transdermal Testosterone gelPlacebo 2 pumps per day for 6 months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women age 18-55
- Hypopituitarism with central adrenal and/or gonadal deficiencies. To qualify patients will need to have either 1 or 2 and they need to have 3:
- No other significant medical condition
- Weight between 80 and 150% of ideal body weight
- Able to provide informed consent
Key exclusion criteria (17 listed)
- Physical disabilities that would prevent them from participating in the study.
- Current use of testosterone or other androgenic steroids. Patients who are taking testosterone, DHEA or other androgen precursors will discontinue these medications/supplements three months prior to the study.
- Significant cardiopulmonary disease (prior myocardial infarction causing ventricular dysfunction, angina, arrhythmias, congestive heart failure, valvular problem), venous thrombotic event (pulmonary embolism or deep vein thrombosis), renal disease (creatinine greater than 1.5 mg/dL), diabetes mellitus on insulin, uncontrolled hypertension, malignancy (other than basal cell skin carcinoma) or major psychiatric disease. Patients with depression or anxiety on a stable dose of medication will be allowed to enroll.
- Current abuse of illicit drugs or heavy ethanol use.
- History of breast cancer or abnormal mammogram at entry. If patients with an abnormal mammogram or PAP smear are appropriately evaluated and found not to have cancer, they will be allowed to participate in the study.
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 |
|---|---|---|
| Transdermal Testosterone gel2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months. | Drug | Placebo, Transdermal Testosterone Gel |
Primary outcome
Fatigue Impact Scale
Time frame: 6 months
change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trial Research siteLink provided by the sponsor.
Related trials for Panhypopituitarism
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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RecruitingPhase 3
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form
Not yet recruiting
Growing up With the Young Endocrine Support System (YESS!)
Congenital Adrenal Hyperplasia, Hypogonadotropic Hypogonadism
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.
Theodore C Friedman, M.D., Ph.D. principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal Testosterone gel in people with Panhypopituitarism, run by Charles Drew University of Medicine and Science at 1 site in United States.
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 10 inclusion and 17 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: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fatigue Impact Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2017.