Ovarian Failure, PrematureNCT01023178
Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
A study testing 17beta Estradiol, Conjugated estrogens and 17Beta Estradiol - transdermal in people with Ovarian Failure, Premature, run by Stanford University at 1 site in United States.
Trial summary
To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Ovarian Failure, Premature
- What is being tested?
- 17beta Estradiol, Conjugated estrogens and 17Beta Estradiol - transdermal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2013
- Phase
- Interventional
- 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 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- spontaneous menses
- significant concurrent medical problem including:
- Liver function tests (LFTs) 3 times normal
- clotting disorder
- ongoing cancer treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure
To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.
Read the detailed description
Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.
- Conditions
- Ovarian Failure, Premature
- Being tested
- 17beta Estradiol, Conjugated estrogens, 17Beta Estradiol - transdermal, Progesterone, micronized
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17beta EstradiolDrug
Also called Estrace
Oral pill given daily at increasing doses every 6 months for 18 months.
Conjugated estrogensDrug
Also called Premarin
Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
17Beta Estradiol - transdermalDrug
Also called Vivelle-Dot
Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Progesterone, micronizedDrug
Also called Prometrium
Given starting at 18 months
| Study group | Role | What they receive |
|---|---|---|
| Vivelle-Dot | Active comparator | 17Beta Estradiol - transdermal Receives: Drug: 17Beta Estradiol - transdermal; Drug: Progesterone, micronized |
| Premarin | Active comparator | Conjugated estrogens Receives: Drug: Conjugated estrogens; Drug: Progesterone, micronized |
| Estrace | Active comparator | 17beta Estradiol Receives: Drug: 17beta Estradiol; Drug: Progesterone, micronized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estradiol
Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
Measured: end of study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startFeb 2007
- Primary completionJun 2013
- Study completionJun 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Failure, PrematureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrell M Wilson, Stanford University
- Investigators
- Darrell M Wilson, Principal investigator, Stanford UniversityE Kirk Neely, Study director, Stanford UniversitySejal Shah, Sub-investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023178
- Sponsor's protocol ID
- SU-10272009-4262
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2009
- Last updated
- 20 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shah S, Forghani N, Durham E, Neely EK. A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism. Int J Pediatr Endocrinol. 2014;2014(1):12. doi: 10.1186/1687-9856-2014-12. Epub 2014 Jun 20.
PubMed 24982681
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure
- ClinicalTrials.gov ID
- NCT01023178
- Acronym / sponsor ID
- SU-10272009-4262
- Conditions
- Ovarian Failure, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 20 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.
Detailed description
Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vivelle-Dot | Active comparator | Drug: 17Beta Estradiol - transdermal, Drug: Progesterone, micronized17Beta Estradiol - transdermal |
| Premarin | Active comparator | Drug: Conjugated estrogens, Drug: Progesterone, micronizedConjugated estrogens |
| Estrace | Active comparator | Drug: 17beta Estradiol, Drug: Progesterone, micronized17beta Estradiol |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- spontaneous menses
- significant concurrent medical problem including:
- Liver function tests (LFTs) 3 times normal
- clotting disorder
- ongoing cancer treatment
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 |
|---|---|---|
| 17beta EstradiolAlso: EstraceOral pill given daily at increasing doses every 6 months for 18 months. | Drug | Estrace |
| Conjugated estrogensAlso: PremarinOral pill, started at a low dose taken daily, dose increased every 6 months for 18 months | Drug | Premarin |
| 17Beta Estradiol - transdermalAlso: Vivelle-DotTransdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months | Drug | Vivelle-Dot |
| Progesterone, micronizedAlso: PrometriumGiven starting at 18 months | Drug | Estrace, Premarin, Vivelle-Dot |
Primary outcome
Estradiol
Time frame: end of study (up to 2 years)
Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24982681Shah S, Forghani N, Durham E, Neely EK. A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism. Int J Pediatr Endocrinol. 2014;2014(1):12. doi: 10.1186/1687-9856-2014-12. Epub 2014 Jun 20.
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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.
Darrell M Wilson principal investigator
Stanford University
E Kirk Neely study director
Stanford University
Sejal Shah sub-investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 17beta Estradiol, Conjugated estrogens and 17Beta Estradiol - transdermal in people with Ovarian Failure, Premature, run by Stanford University 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 0 inclusion and 5 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 20 Jan 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?
Yes. Results are posted in the registry (first posted 20 Jan 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?
Estradiol (time frame: end of study (up to 2 years)). 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 NCT01023178, 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 Jan 2017.