HypopituitarismNCT00027430
Androgen Replacement Therapy in Women With Hypopituitarism
A study testing TheraDerm in people with Hypopituitarism, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a study to determine whether testosterone replacement with TheraDerm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypopituitarism
- What is being tested?
- TheraDerm
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Dec 2004
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hypogonadism and/or hypoadrenalism of central origin
- Testosterone or free testosterone level below the median for age-matched normal controls
- Prior estrogen preparation for at least 6 months
Who cannot join
- Any disease known to affect bone metabolism, including untreated hypothyroidism or hyperthyroidism
- Change in thyroid hormone dose in the last 3 months
- Untreated Cushing's syndrome
- Renal failure
- Alcoholism
- Anorexia nervosa
Show all 13Show fewer
- Prior use of medication known to affect bone metabolism (e.g., supraphysiologic doses of glucocorticoids, phenytoin, bisphosphonates, or calcitonin) within the past 3 months
- Pregnant or nursing
- Uncontrolled hypertension
- ALT greater than 3 times upper limit of normal
- Serum creatinine greater than 2 times the upper limit of normal
- Any contraindication to estrogen therapy, including history of breast cancer or undiagnosed uterine bleeding
- Concurrent growth hormone replacement therapy, if patient has been receiving it for less than 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: TheraDerm Administration in Women With Hypopituitarism
This is a study to determine whether testosterone replacement with TheraDerm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism.
Read the detailed description
Patients will be randomized into 2 groups to receive testosterone replacement therapy or placebo. Group 1 will receive 2 testosterone patches and estrogen pills for 12 months. Group 2 will receive 2 placebo patches and estrogen pills for 12 months. Changes in bone density, bone metabolism markers, body composition, libido, and quality of life will be compared in the women receiving testosterone replacement therapy with that of the women receiving placebo.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Hypopituitarism
- Being tested
- TheraDerm
- Medical subject headings
- Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraDermDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2001 (estimated)
- Study startSep 2001
- Study completionDec 2004
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 HypopituitarismStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Anne Klibanski, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027430
- Sponsor's protocol ID
- FD-R-1981-01
- Other IDs
- FD-R-001981-01
- Status last verified
- Nov 2001
- First submitted
- 5 Dec 2001
- Last updated
- 25 Mar 2015
- Results posted
- No
Publications
Lin E, McCabe E, Newton-Cheh C, Bloch K, Buys E, Wang T, Miller KK. Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study. Fertil Steril. 2012 Feb;97(2):489-93. doi: 10.1016/j.fertnstert.2011.11.001. Epub 2011 Dec 2.
PubMed 22137497
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheraDerm Administration in Women With Hypopituitarism
- ClinicalTrials.gov ID
- NCT00027430
- Acronym / sponsor ID
- FD-R-1981-01
- Conditions
- Hypopituitarism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2001
- Study completion
- Dec 2004
- First posted
- 7 Dec 2001 (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.
This is a study to determine whether testosterone replacement with TheraDerm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism.
Detailed description
Patients will be randomized into 2 groups to receive testosterone replacement therapy or placebo. Group 1 will receive 2 testosterone patches and estrogen pills for 12 months. Group 2 will receive 2 placebo patches and estrogen pills for 12 months. Changes in bone density, bone metabolism markers, body composition, libido, and quality of life will be compared in the women receiving testosterone replacement therapy with that of the women receiving placebo.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hypogonadism and/or hypoadrenalism of central origin
- Testosterone or free testosterone level below the median for age-matched normal controls
- Prior estrogen preparation for at least 6 months
Key exclusion criteria (13 listed)
- Any disease known to affect bone metabolism, including untreated hypothyroidism or hyperthyroidism
- Change in thyroid hormone dose in the last 3 months
- Untreated Cushing's syndrome
- Renal failure
- Alcoholism
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 |
|---|---|---|
| TheraDerm | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Derived from this study: PubMed 22137497Lin E, McCabe E, Newton-Cheh C, Bloch K, Buys E, Wang T, Miller KK. Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study. Fertil Steril. 2012 Feb;97(2):489-93. doi: 10.1016/j.fertnstert.2011.11.001. Epub 2011 Dec 2.
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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.
Anne Klibanski, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraDerm in people with Hypopituitarism, run by Massachusetts General Hospital 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 3 inclusion and 13 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 25 Mar 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027430, 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 25 Mar 2015.