PanhypopituitarismNCT00144404
Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women With Hypopituitarism
An observational study of Panhypopituitarism, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
The purpose of this study is to determine the blood levels of testosterone gel administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a normal range for women. 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
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Aug 2002
- Phase
- Observational
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age 18-55
- Hypopituitarism with documented central adrenal and gonadal deficiencies. Serum testosterone level of < 20 ng/dl or free testosterone <1.5 pg/ml on conjugated equine estrogen replacement
- No other significant medical condition
- 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, renal disease (creatinine > 1.5 mg/dL), diabetes mellitus, 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 or uterine cancer
- Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline phosphatase value of greater than one and one-half times 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
- 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 > 50%
- Male sex
- Not willing to answer all questions on surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University
Los Angeles, California, 90059
About this study
The purpose of this study is to determine the blood levels of testosterone gel administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a normal range for women. An additional objective is to determine the baseline laboratory abnormalities and physical, brain function, emotional and sexual symptomatology of these women with hypopituitarism.
Read the detailed description
The ovaries and the adrenal glands contribute to the daily production of 300 micrograms of testosterone in healthy, menstruating women. The physiologic role of testosterone in women, however, remains poorly understood. Previous studies of testosterone supplementation, largely in surgically or naturally menopausal women, have reported improvements in subjective measures of sexual function, sense of well being, and variable changes in markers of bone formation and resorption. However, many of these previous studies used supraphysiologic doses of testosterone, and insensitive assays for the measurement of total and free testosterone levels that lacked precision and accuracy in the low range prevalent in women. The effects of testosterone in women on body composition, muscle performance and physical function have not been studied. Therefore, the clinical significance of androgen deficiency in women remains unclear. Thus, we do not know whether physiologic testosterone replacement of women with androgen deficiency can produce clinically meaningful improvements in sexual and cognitive functions, fat-free mass, and muscle performance, without virilizing side effects.
Women with hypopituitarism represent an excellent model to study the effects of physiologic replacement as these patients have severely diminished androgen production from both the adrenal glands and the ovaries. Estrogen administration, by increasing sex hormone binding globulin (SHBG) in these women leads to further reduction in free testosterone concentrations. In fact, a recent study demonstrated very low levels of total and free testosterone, dehydroepiandrosterone sulfate (DHEAS), its parent steroid dehydroepiandrosterone (DHEA), and androstenedione in women with hypopituitarism. Therefore, it is postulated that many women with hypopituitarism suffer from decreased libido, altered body composition, and impaired quality of life, symptoms possibly related to androgen deficiency. However, these parameters have not been properly studied in a well-defined group of women with hypopituitarism. These baseline studies are needed prior to undertaking a study on treating women with hypopituitarism with a testosterone preparation.
Prior to investigating testosterone replacement in a large study of women with hypopituitarism, we must first determine in this pilot study the amount and interval of testosterone administration.
Currently, the only FDA-approved drug for testosterone in women is Estratest, which contains methyl testosterone, a compound that when given orally is associated with liver toxicity in animals and humans. Until recently, most hypogonadal men received biweekly intramuscular injections of testosterone. This regimen gives variable serum testosterone levels depending on the time of the blood sampling compared to the time of injection. Many male hypogonadal patients now receive their testosterone replacement via either transdermal testosterone gel or patch, with much more uniform serum testosterone levels. We have chosen transdermal testosterone gel for use in this study for several reasons:
- Recent studies have shown that stable, reproducible levels of serum testosterone can be obtained irrespective of application site in hypogonadal men. No skin irritation (which can be problematic with the testosterone patch) was observed.
- Graded Double-blinded dosing can easily be implemented.
Thus, we will use transdermal testosterone gel as it provides predictable and physiologic levels of testosterone.
- Conditions
- Panhypopituitarism
- Medical subject headings
- Combined Pituitary Hormone Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to determine the pharmacokinetics of testosterone gel 2 mg/d administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a physiologic range.
Measured: 6 weeks
Secondary outcomes (1)
An additional objective is to determine the baseline laboratory abnormalities and physical, cognitive, emotional and sexual symptomatology of these women with hypopituitarism.
Measured: 6 weeks
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 startAug 2002
- Primary completionAug 2002
- Study completionAug 2002
Why it stopped: this was not a clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Investigators
- Ted C Friedman, M.D., Ph.D., Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144404
- Sponsor's protocol ID
- 02-04-376-07
- Status last verified
- Apr 2017
- First submitted
- 1 Sep 2005
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women With Hypopituitarism
- ClinicalTrials.gov ID
- NCT00144404
- Acronym / sponsor ID
- 02-04-376-07
- Conditions
- Panhypopituitarism
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: this was not a clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 5 Sep 2005 (estimated)
- 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.
The purpose of this study is to determine the blood levels of testosterone gel administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a normal range for women. An additional objective is to determine the baseline laboratory abnormalities and physical, brain function, emotional and sexual symptomatology of these women with hypopituitarism.
Detailed description
The ovaries and the adrenal glands contribute to the daily production of 300 micrograms of testosterone in healthy, menstruating women. The physiologic role of testosterone in women, however, remains poorly understood. Previous studies of testosterone supplementation, largely in surgically or naturally menopausal women, have reported improvements in subjective measures of sexual function, sense of well being, and variable changes in markers of bone formation and resorption. However, many of these previous studies used supraphysiologic doses of testosterone, and insensitive assays for the measurement of total and free testosterone levels that lacked precision and accuracy in the low range prevalent in women. The effects of testosterone in women on body composition, muscle performance and physical function have not been studied. Therefore, the clinical significance of androgen deficiency in women remains unclear. Thus, we do not know whether physiologic testosterone replacement of women with androgen deficiency can produce clinically meaningful improvements in sexual and cognitive functions, fat-free mass, and muscle performance, without virilizing side effects.
Women with hypopituitarism represent an excellent model to study the effects of physiologic replacement as these patients have severely diminished androgen production from both the adrenal glands and the ovaries. Estrogen administration, by increasing sex hormone binding globulin (SHBG) in these women leads to further reduction in free testosterone concentrations. In fact, a recent study demonstrated very low levels of total and free testosterone, dehydroepiandrosterone sulfate (DHEAS), its parent steroid dehydroepiandrosterone (DHEA), and androstenedione in women with hypopituitarism. Therefore, it is postulated that many women with hypopituitarism suffer from decreased libido, altered body composition, and impaired quality of life, symptoms possibly related to androgen deficiency. However, these parameters have not been properly studied in a well-defined group of women with hypopituitarism. These baseline studies are needed prior to undertaking a study on treating women with hypopituitarism with a testosterone preparation.
Prior to investigating testosterone replacement in a large study of women with hypopituitarism, we must first determine in this pilot study the amount and interval of testosterone administration.
Currently, the only FDA-approved drug for testosterone in women is Estratest, which contains methyl testosterone, a compound that when given orally is associated with liver toxicity in animals and humans. Until recently, most hypogonadal men received biweekly intramuscular injections of testosterone. This regimen gives variable serum testosterone levels depending on the time of the blood sampling compared to the time of injection. Many male hypogonadal patients now receive their testosterone replacement via either transdermal testosterone gel or patch, with much more uniform serum testosterone levels. We have chosen transdermal testosterone gel for use in this study for several reasons:
- Recent studies have shown that stable, reproducible levels of serum testosterone can be obtained irrespective of application site in hypogonadal men. No skin irritation (which can be problematic with the testosterone patch) was observed.
- Graded Double-blinded dosing can easily be implemented.
Thus, we will use transdermal testosterone gel as it provides predictable and physiologic levels of testosterone.
Study design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women age 18-55
- Hypopituitarism with documented central adrenal and gonadal deficiencies. Serum testosterone level of < 20 ng/dl or free testosterone <1.5 pg/ml on conjugated equine estrogen replacement
- No other significant medical condition
- Weight between 80 and 150% of ideal body weight
- Able to provide informed consent
Key exclusion criteria (14 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, renal disease (creatinine > 1.5 mg/dL), diabetes mellitus, 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 or uterine cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The purpose of this study is to determine the pharmacokinetics of testosterone gel 2 mg/d administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a physiologic range.
Time frame: 6 weeks
1 secondary outcome
An additional objective is to determine the baseline laboratory abnormalities and physical, cognitive, emotional and sexual symptomatology of these women with hypopituitarism.
Time frame: 6 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 18 Apr 2017.
- Clinical Trial Research siteLink provided by the sponsor.
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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.
Ted 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?
An observational study of 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 7 inclusion and 14 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 18 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The purpose of this study is to determine the pharmacokinetics of testosterone gel 2 mg/d administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a physiologic range. (time frame: 6 weeks). 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 18 Apr 2017.