MenopausePhase 4NCT00224094
A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
A Phase 4 study testing Premarin® (oral) vs. Alora® (transdermal) in people with Menopause, run by Watson Pharmaceuticals at 1 site in United States.
Trial summary
This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women. Read more about this study
- Who is it for?
- Ages 42 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Premarin® (oral) vs. Alora® (transdermal)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to May 2003
- Phase
- Phase 4
- 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 42 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Naturally menopausal women
- Aged 42-70 years
- Currently using combination estrogen-progestin replacement therapy
Who cannot join
- Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events
- Thyroid disease
- Adrenal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women
This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.
- Conditions
- Menopause
- Being tested
- Premarin® (oral) vs. Alora® (transdermal)
- Keywords
- Menopause, Testosterone, Androgens, Sex Hormone Binding Globulin, Thyroid function, Cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premarin® (oral) vs. Alora® (transdermal)Drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Oral ERT then transdermal ERT Receives: Drug: Premarin® (oral) vs. Alora® (transdermal) |
| Sequence B | Experimental | Transdermal ERT then oral ERT Receives: Drug: Premarin® (oral) vs. Alora® (transdermal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women.
Measured: 12 weeks
Secondary outcomes (2)
Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.
Measured: 12 weeks
Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.
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 posted22 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Jan L Shifren, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224094
- Sponsor's protocol ID
- ALO0102
- Status last verified
- Oct 2012
- First submitted
- 14 Sep 2005
- Last updated
- 15 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women
- ClinicalTrials.gov ID
- NCT00224094
- Acronym / sponsor ID
- ALO0102
- Conditions
- Menopause
- Keywords
- Menopause, Testosterone, Androgens, Sex Hormone Binding Globulin, Thyroid function, Cortisol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- Jan 2002
- Primary completion
- May 2003 (actual)
- First posted
- 22 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.
This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Premarin® (oral) vs. Alora® (transdermal)Oral ERT then transdermal ERT |
| Sequence B | Experimental | Drug: Premarin® (oral) vs. Alora® (transdermal)Transdermal ERT then oral ERT |
Who may qualify
- Ages
- 42 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy
- Naturally menopausal women
- Aged 42-70 years
- Currently using combination estrogen-progestin replacement therapy
Key exclusion criteria (3 listed)
- Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events
- Thyroid disease
- Adrenal disease
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 |
|---|---|---|
| Premarin® (oral) vs. Alora® (transdermal) | Drug | Sequence A, Sequence B |
Primary outcome
Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women.
Time frame: 12 weeks
2 secondary outcomes
Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.
Time frame: 12 weeks
Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.
Time frame: 12 weeks
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 15 Oct 2012.
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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.
Jan L Shifren, MD 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 Phase 4 study testing Premarin® (oral) vs. Alora® (transdermal) in people with Menopause, run by Watson Pharmaceuticals 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 4 inclusion and 3 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 15 Oct 2012. 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.
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?
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.
What does the primary outcome measure?
Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women. (time frame: 12 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 15 Oct 2012.