Hot FlashesNCT00547001
Comparison of Hormonal Therapy: Mediating Hot Flashes Tapering Regimens for Mediating Hot Flashes
A study testing Estradiol in people with Hot Flashes and Night Sweats, run by Hartford Hospital at 1 site in United States.
Trial summary
This study will evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Night Sweats
- What is being tested?
- Estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2009
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female.
- ages 35-70, inclusive.
- Postmenopausal (Natural or surgical: see definitions).
- Currently on HT/ET for at least 6 months for vasomotor symptomatology.
- Vasomotor symptoms are currently controlled on medication .
- An annual physical \& pelvic exam has been performed within the last 12mo
- The patient has had a normal mammogram(BIRADS I/II) within the last 24mo
Who cannot join
- Males
- Hypertension, defined as either SBP >140 mmHg or DBP >90 mmHg
- Lack of compliance (willingness to adhere to protocol)
- Inability or unwillingness to swallow pills
- Patients with any contraindications to HT/ET
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Margarita Garcia, 860-545-2196
About this study
Official title: A Comparison of Hormonal Therapy: Tapering Regimens for Mediating Hot Flashes
This study will evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the frequency (number of occurrences per week), severity (defined as a subjective scale mild, moderate, or severe), and "Severity Index" (SI, equaling the product of both) of hot flashes between three tapering schedules for one accepted HT/ET regimen.
Read the detailed description
A Comparison of Hormonal Therapy:
Tapering Regimens for Mediating Hot Flashes
Clinicians have been asking for years whether a tapering dose of HT would make a difference in the frequency and severity of vasomotor symptoms after menopausal women stop HT therapy. This planned randomized, placebo-controlled trial (RCT) seeks to evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the frequency (number of occurrences per week), severity (defined as a subjective scale mild, moderate, or severe), and "Severity Index" (SI, equaling the product of both) of hot flashes between three tapering schedules for one accepted HT/ET regimen.
All participants will be randomized to one of the three arms (taper arm, placebo arm, and "cold turkey" arm). Each patient's gynecologist will be aware of the patient's involvement in the study and will assist by providing baseline safety information. All patients will be taken off their current HT/ET regimen and will be placed on study medication (1 mg of Estradiol PO every day for 8 weeks, "stabilization" phase). After the 8-week stabilization period, all participants will begin the therapy corresponding to the arm to which they were randomized. Each patient in the taper or placebo arm will take one capsule per day. The patients in the "cold turkey" arm will discontinued acutely after the stabilization.
The patients will keep a diary of the number and frequency of symptoms during the study. Patients will be contacted by phone to confirm that they are completing their diaries and that they have not developed side effects or complications that could force their discontinuation from the study.
Patients will be followed for several additional weeks, after discontinuation from treatment or placebo, to monitor for symptoms. At the end of the study, our coordinator will contact the patient to assure that Medroxyprogesterone acetate, MPA, was taken properly by those women who have a uterus. They will also confirm that no other symptoms, complications, or questions have arisen. At that time, they will be able to return to their prior therapy as deemed appropriate by them and their physician.
Patients will be recruited by invitation upon presenting for care to their physician. With invitations at recruitment, all patients will be given a study form. Reasons for ineligibility or refusal will be noted. After expressing interest, the physician or practice of record will sign a form acknowledging that their patient has had an annual physical exam (including pelvic exam) within the last 12 months and that a mammogram has been reported as negative (BIRADS I or II) within the last 24 months. An appointment will be made with one of our study personnel or coordinators. The patient will bring the signed form to this visit. At this enrollment / consent visit, their eligibility criteria will be reviewed. All patients will sign the informed consent, and be randomized to a group.
- Conditions
- Hot Flashes, Night Sweats
- Being tested
- Estradiol
- Keywords
- Menopause, Hot flashes, vasomotor symptoms, tapering regimen, hormonal therapy, Other menopausal symptoms including mood changes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
1mg during stabilization \& then a taper to 0.75mg, 0.5mg, 0.25mg, 0.125mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group A will be tapered over 4 weeks, starting at baseline (week 0). Subjects in this group will take one tablet of ET daily (effective dose, 0.75 mg) for week 1, then one 0.50 mg tablet daily for week 2, then one 0.25 mg tablet daily for week 3, and finally one 0.125 mg tablet daily for week 4. Receives: Drug: Estradiol |
| 2 | Placebo comparator | Group B will be administered placebo. These tablets will appear identical to those administered to subjects in Group A, but the tablets will contain no estrogen. Subjects in this group will be instructed to take one pill every day for the 4 weeks. Thus, while patients will, in effect, be stopped abruptly from their therapy, there is still the potential of a placebo effect. Receives: Drug: Estradiol |
| 3 | No intervention | Group C will have their therapy discontinued acutely at baseline (week 0); i.e., these subjects will not take any tablets after the 8-week stabilization phase ends. While we recognize that this group will not be blinded to the regimen they are receiving, we feel that group C will be important to include in light of the consistent decrease in vasomotor symptoms experienced by women taking placebo. Because women taking placebo have approximately a 35% decrease in vasomotor symptoms, it will be important to compare our taper regimen to the "real life" scenario of stopping medication abruptly. Receives: Drug: Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen.
Measured: During the tapering and post taper time period.
Secondary outcomes (1)
frequency, severity, and "Severity Index" of hot flashes.
Measured: During the tapering and post taper time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startAug 2007
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peter F. Schnatz, D.O., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547001
- Sponsor's protocol ID
- SCHN002140HI
- Status last verified
- Jul 2008
- First submitted
- 17 Oct 2007
- Last updated
- 18 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Hormonal Therapy: Tapering Regimens for Mediating Hot Flashes
- ClinicalTrials.gov ID
- NCT00547001
- Acronym / sponsor ID
- SCHN002140HI
- Conditions
- Hot Flashes, Night Sweats
- Keywords
- Menopause, Hot flashes, vasomotor symptoms, tapering regimen, hormonal therapy, Other menopausal symptoms including mood changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Nov 2009 (estimated)
- First posted
- 19 Oct 2007 (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 will evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the frequency (number of occurrences per week), severity (defined as a subjective scale mild, moderate, or severe), and "Severity Index" (SI, equaling the product of both) of hot flashes between three tapering schedules for one accepted HT/ET regimen.
Detailed description
A Comparison of Hormonal Therapy:
Tapering Regimens for Mediating Hot Flashes
Clinicians have been asking for years whether a tapering dose of HT would make a difference in the frequency and severity of vasomotor symptoms after menopausal women stop HT therapy. This planned randomized, placebo-controlled trial (RCT) seeks to evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the frequency (number of occurrences per week), severity (defined as a subjective scale mild, moderate, or severe), and "Severity Index" (SI, equaling the product of both) of hot flashes between three tapering schedules for one accepted HT/ET regimen.
All participants will be randomized to one of the three arms (taper arm, placebo arm, and "cold turkey" arm). Each patient's gynecologist will be aware of the patient's involvement in the study and will assist by providing baseline safety information. All patients will be taken off their current HT/ET regimen and will be placed on study medication (1 mg of Estradiol PO every day for 8 weeks, "stabilization" phase). After the 8-week stabilization period, all participants will begin the therapy corresponding to the arm to which they were randomized. Each patient in the taper or placebo arm will take one capsule per day. The patients in the "cold turkey" arm will discontinued acutely after the stabilization.
The patients will keep a diary of the number and frequency of symptoms during the study. Patients will be contacted by phone to confirm that they are completing their diaries and that they have not developed side effects or complications that could force their discontinuation from the study.
Patients will be followed for several additional weeks, after discontinuation from treatment or placebo, to monitor for symptoms. At the end of the study, our coordinator will contact the patient to assure that Medroxyprogesterone acetate, MPA, was taken properly by those women who have a uterus. They will also confirm that no other symptoms, complications, or questions have arisen. At that time, they will be able to return to their prior therapy as deemed appropriate by them and their physician.
Patients will be recruited by invitation upon presenting for care to their physician. With invitations at recruitment, all patients will be given a study form. Reasons for ineligibility or refusal will be noted. After expressing interest, the physician or practice of record will sign a form acknowledging that their patient has had an annual physical exam (including pelvic exam) within the last 12 months and that a mammogram has been reported as negative (BIRADS I or II) within the last 24 months. An appointment will be made with one of our study personnel or coordinators. The patient will bring the signed form to this visit. At this enrollment / consent visit, their eligibility criteria will be reviewed. All patients will sign the informed consent, and be randomized to a group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EstradiolGroup A will be tapered over 4 weeks, starting at baseline (week 0). Subjects in this group will take one tablet of ET daily (effective dose, 0.75 mg) for week 1, then one 0.50 mg tablet daily for week 2, then one 0.25 mg tablet daily for week 3, and finally one 0.125 mg tablet daily for week 4. |
| 2 | Placebo comparator | Drug: EstradiolGroup B will be administered placebo. These tablets will appear identical to those administered to subjects in Group A, but the tablets will contain no estrogen. Subjects in this group will be instructed to take one pill every day for the 4 weeks. Thus, while patients will, in effect, be stopped abruptly from their therapy, there is still the potential of a placebo effect. |
| 3 | No intervention | Drug: EstradiolGroup C will have their therapy discontinued acutely at baseline (week 0); i.e., these subjects will not take any tablets after the 8-week stabilization phase ends. While we recognize that this group will not be blinded to the regimen they are receiving, we feel that group C will be important to include in light of the consistent decrease in vasomotor symptoms experienced by women taking placebo. Because women taking placebo have approximately a 35% decrease in vasomotor symptoms, it will be important to compare our taper regimen to the "real life" scenario of stopping medication abruptly. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female.
- ages 35-70, inclusive.
- Postmenopausal (Natural or surgical: see definitions).
- Currently on HT/ET for at least 6 months for vasomotor symptomatology.
- Vasomotor symptoms are currently controlled on medication .
Key exclusion criteria (5 listed)
- Males
- Hypertension, defined as either SBP >140 mmHg or DBP >90 mmHg
- Lack of compliance (willingness to adhere to protocol)
- Inability or unwillingness to swallow pills
- Patients with any contraindications to HT/ET
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 |
|---|---|---|
| Estradiol1mg during stabilization \& then a taper to 0.75mg, 0.5mg, 0.25mg, 0.125mg. | Drug | 1, 2, 3 |
Primary outcome
To evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen.
Time frame: During the tapering and post taper time period.
1 secondary outcome
frequency, severity, and "Severity Index" of hot flashes.
Time frame: During the tapering and post taper time period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2008.
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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.
Peter F. Schnatz, D.O. principal investigator
Hartford 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 Estradiol in people with Hot Flashes and Night Sweats, run by Hartford 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 7 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: status not confirmed, as of the sponsor's last update on 18 Jul 2008. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Lynne Hosig, RN (860-545-1005, LHOSIG@harthosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. (time frame: During the tapering and post taper time period.). 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 Jul 2008.