Trial · NCT00302731
Bioidentical 'Natural' Hormone Evaluation in Early Menopause
NCT00302731, Phase 2, Terminated, Jeanne Drisko, MD, CNS, FACN; results first posted 2018-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioidentical 'Natural' Hormone Evaluation in Early Menopause. Trials, record NCT00302731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00302731
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioidentical 'Natural' Hormone Evaluation in Early Menopause
- NCT number
- NCT00302731
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Jeanne Drisko, MD, CNS, FACN
- Conditions
- Menopause
- Interventions
- Estradiol , estriol , progesterone, estradiol, progesterone, estriol, progesterone, equine estrogens m-progesteroneacetate
- First posted
- 2006-03-14
- Last updated
- 2018-07-06
- Results first posted
- 2018-05-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Cholesterol | Baseline and month 12 | To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion. |
| Primary | Endometrial Measurement | Baseline and month 12 | Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion. |
| Primary | Number of Participants Without Change in Baseline and Follow up Mammograms | baseline and month 12 | Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below. |
| Secondary | Number of Participants Without Change in Baseline and Follow up Bone Density | baseline and 12 months | Comparison at baseline and month 12 by descriptive analysis of bone density. Assessing for changes in density related to hormone replacement therapy. Bone density readings for participants completing study in descriptive terms. Looking for significant change in bone density while on hormone therapy for 12 months. Those who had no change are counted below. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Cholesterol | Baseline and month 12 | mg/dL | MEAN | |
| PRIMARY | Endometrial Measurement | Baseline and month 12 | mm | MEAN | |
| PRIMARY | Number of Participants Without Change in Baseline and Follow up Mammograms | baseline and month 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Without Change in Baseline and Follow up Bone Density | baseline and 12 months | Only 7 participants completed both the baseline bone density and 12-month follow up bone density resulting in a discrepancy in evaluable numbers compared to other outcome measures. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Cholesterol | Study Arm 1 | 221.5 | Standard Deviation 12.5 | mg/dL | |
| Change in Total Cholesterol | Study Arm 2 | 221.5 | Standard Deviation 0 | mg/dL | |
| Change in Total Cholesterol | Study Arm 3 | 223 | Standard Deviation 26 | mg/dL | |
| Change in Total Cholesterol | Study Arm 4 | 165.5 | Standard Deviation 11 | mg/dL | |
| Endometrial Measurement | Study Arm 1 | 13.0 | Standard Deviation 0 | mm | |
| Endometrial Measurement | Study Arm 2 | 10.0 | Standard Deviation 0 | mm | |
| Endometrial Measurement | Study Arm 3 | 2.5 | Standard Deviation 0.7 | mm | |
| Endometrial Measurement | Study Arm 4 | 3.1 | Standard Deviation 0.7 | mm | |
| Number of Participants Without Change in Baseline and Follow up Mammograms | Study Arm 1 | 2 | Participants | ||
| Number of Participants Without Change in Baseline and Follow up Mammograms | Study Arm 2 | 1 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Randomized to Arm 1 | 6 | |
| Overall Study | STARTED | Participants Randomized to Arm 2 | 6 | |
| Overall Study | STARTED | Participants Randomized to Arm 3 | 5 | |
| Overall Study | STARTED | Participants Randomized to Arm 4 | 4 | |
| Overall Study | COMPLETED | Participants Randomized to Arm 1 | 2 | |
| Overall Study | COMPLETED | Participants Randomized to Arm 2 | 1 | |
| Overall Study | COMPLETED | Participants Randomized to Arm 3 | 2 | |
| Overall Study | COMPLETED | Participants Randomized to Arm 4 | 4 | |
| Overall Study | NOT COMPLETED | Participants Randomized to Arm 1 | 4 | |
| Overall Study | NOT COMPLETED | Participants Randomized to Arm 2 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abnormal vaginal bleeding | Reproductive system and breast disorders | Study Arm 1 | 0 | 6 | 0 |
| other | Abnormal vaginal bleeding | Reproductive system and breast disorders | Study Arm 2 | 1 | 6 | 1 |
| other | Abnormal vaginal bleeding | Reproductive system and breast disorders | Study Arm 3 | 2 | 5 | 2 |
| other | Abnormal vaginal bleeding | Reproductive system and breast disorders | Study Arm 4 | 0 | 4 | 0 |
| other | Lethargy | Metabolism and nutrition disorders | Study Arm 1 | 0 | 6 | 0 |
| other | Lethargy | Metabolism and nutrition disorders | Study Arm 2 | 1 | 6 | 1 |
| other | Lethargy | Metabolism and nutrition disorders | Study Arm 3 | 0 | 5 | 0 |
| other | Lethargy | Metabolism and nutrition disorders | Study Arm 4 | 0 | 4 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Arm 1 | 0 | 6 |
| Total, all-cause mortality | Study Arm 2 | 0 | 6 |
| Total, all-cause mortality | Study Arm 3 | 0 | 5 |
| Total, all-cause mortality | Study Arm 4 | 0 | 4 |
| Total, other adverse events | Study Arm 1 | 0 | 6 |
| Total, other adverse events | Study Arm 2 | 2 | 6 |
| Total, other adverse events | Study Arm 3 | 2 | 5 |
| Total, other adverse events | Study Arm 4 | 0 | 4 |
| Total, serious adverse events | Study Arm 1 | 0 | 6 |
| Total, serious adverse events | Study Arm 2 | 0 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00302731
GET https://conductscience.org/api/trials/v1/NCT00302731/registered