Trial · NCT03568708
Primary Ovarian Insufficiency: Phenotype and Optimal Treatment
NCT03568708, Phase 3, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2024-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Primary Ovarian Insufficiency: Phenotype and Optimal Treatment. Trials, record NCT03568708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03568708
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Primary Ovarian Insufficiency: Phenotype and Optimal Treatment
- NCT number
- NCT03568708
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 19 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Primary Ovarian Insufficiency
- Interventions
- Transdermal Estrogen
- First posted
- 2018-06-26
- Last updated
- 2024-06-25
- Results first posted
- 2024-06-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) of the Lumbar Spine | Change in bone mineral density and body composition from baseline to 24 months | Change in height adjusted areal BMD Z-score of the lumbar spine from baseline to 24 months within groups. BMI Z-score, calcium intake, vitamin D intake and physical activity were included in the analysis. As DXA BMD Z-scores already include race, age, and sex, these variables were not included in the analysis. Z-scores ranging between -2.0 and 2.0 are considered normal. A Z-score \<-2.0 is considered low. This analysis considers change in Z-score, therefore a high value reflects a greater increase in BMD Z-score. |
| Secondary | Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | baseline to 24 months | To assess changes in bone mineral density DXA height adjusted BMD Z-scores of the whole body less head, total hip and femoral neck were measured. BMI, calcium intake, vitamin D intake and physical activity were included in the analysis. As DXA BMD Z-scores already include race, age, and sex, these variables were not included in the analysis. Z-scores ranging between -2.0 and 2.0 are considered normal. A Z-score \<-2.0 is considered low. This analysis considers change in Z-score, therefore a high value reflects a greater increase in BMD Z-score. |
| Secondary | Change in Volumetric Bone Mineral Density (vBMD) at the Distal Radius as Measured by Peripheral Quantitative Computed Tomography (pQCT) | Change from baseline to 24 months | To assess the appendicular (peripheral) skeleton, pQCT (Stratec XCT 2000, Orthometrix, Inc., White Plains, NY) bone measures were obtained of the non-dominant radius at the 3% and 66% sites. Measurements were acquired with a voxel size of 0.4 mm, slice thickness of 2.3 mm, and scan speed of 25 mm/sec, and analyzed with manufacturer software version 6. |
| Secondary | Anthropometrics | Baseline and 24 months | The mean BMI in kg/m\^2 is presented for each study group at baseline and at the 24 months follow up visit to show that there was no significant difference between groups nor a significant change in BMI over the duration of the study. |
| Secondary | Change in Lean Mass as Measured by DXA Body Composition | Change in lean mass from baseline to 24 months | Lean mass was obtained from the whole body DXA scan. Change in baseline to 24 months was assessed. |
| Secondary | Change in Symptoms of Anxiety as Measured by Screen for Child Anxiety Related Disorders (SCARED) | Change from SCARED score baseline to 24 months | A 41 item self-report tool to assess for anxiety where each question receives a score of either 0, 1 or 2. Range of scores is 0 to 82. A total score of ≥ 25 may indicate the presence of an Anxiety Disorder. A higher score indicates there are more endorsed symptoms of anxiety. |
| Secondary | Change in Symptoms of Depression as Measured by Child Depression Inventory-II (CDI-II) | Change from CDI-II score from baseline to 24 months | A brief self-report test that helps assess cognitive, affective and behavioral signs of depression in children and adolescents 7 to 17 years old. Scales include Emotional and Functional Problems, along with subscales of Negative mood/Physical symptoms, Negative Self-Esteem, Interpersonal Problems, and Ineffectiveness. The total score is converted into a T-score (mean=50, standard deviation=10) where a result \>64 is considered elevated. A higher score indicates there are more endorsed symptoms of depression. |
| Secondary | Change in Memory as Assessed by the Children and Adolescent Memory Profile (CHAMP) Total Memory Index Score | Change from score from baseline to 24 months | The ChAMP is a norm-referenced test of memory and learning that was designed for use with children, adolescents, and young adults ranging from 5 through 21 years. The ChAMP includes 4 Subtests of visual and verbal memory to generate a total memory index score as a measure of overall memory. The total memory index score ranges from 50-150 with a mean=100 and standard deviation=15. Higher scores indicating better memory. The data presented here is the change in the total memory index score from baseline visit to the 24 month follow up time. |
| Secondary | Change in Quality of Life as Assessed by the Child Health Questionnaire-Child Self-Report Form (CHQ-CF87) | Change from baseline to 24 months | The CHQ-87 is an 87-item self-report survey is designed to measure the physical and psychosocial health of adolescents. The total score ranges from 0-100. Higher scores indicate better quality of life. This instrument is reliable and valid for evaluating aspects of health pertinent across age, gender, health condition, and socioeconomic status in adolescents. |
| Secondary | Compliance With Transdermal Estrogen Patch | Patch Calendars were collected at 6 months, 12 months, 18 months and 24 months. Data presented is through study completion. | Participants with primary ovarian insufficiency (POI) were prescribed weekly transdermal estrogen (TDE2) patches and asked to log on a patch calendar when they changed the patch. Patch calendars were reviewed for compliance and weeks where at least one patch was applied were considered to be in compliance. Weeks in compliance generated the numerator whereas total weeks of participation in the study constituted the numerator. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) of the Lumbar Spine | Change in bone mineral density and body composition from baseline to 24 months | One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses. | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | baseline to 24 months | One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses. | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Volumetric Bone Mineral Density (vBMD) at the Distal Radius as Measured by Peripheral Quantitative Computed Tomography (pQCT) | Change from baseline to 24 months | One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses. | mg/mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Anthropometrics | Baseline and 24 months | kg/m^2 | MEAN | |
| SECONDARY | Change in Lean Mass as Measured by DXA Body Composition | Change in lean mass from baseline to 24 months | One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Symptoms of Anxiety as Measured by Screen for Child Anxiety Related Disorders (SCARED) | Change from SCARED score baseline to 24 months | One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Symptoms of Depression as Measured by Child Depression Inventory-II (CDI-II) | Change from CDI-II score from baseline to 24 months | One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Memory as Assessed by the Children and Adolescent Memory Profile (CHAMP) Total Memory Index Score | Change from score from baseline to 24 months | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Quality of Life as Assessed by the Child Health Questionnaire-Child Self-Report Form (CHQ-CF87) | Change from baseline to 24 months | One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Compliance With Transdermal Estrogen Patch | Patch Calendars were collected at 6 months, 12 months, 18 months and 24 months. Data presented is through study completion. | As only participants with POI were prescribed TDE2 patches, we only report data on this cohort. | percentage of weeks with TDE2 use | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) of the Lumbar Spine | Control Participants | 0.228 | Standard Deviation 0.289 | Z-score | |
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) of the Lumbar Spine | POI Participants | 0.673 | Standard Deviation 0.289 | Z-score | |
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | Control Participants | Whole Body Less Head | 0.433 | Standard Deviation 0.199 | Z-score |
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | POI Participants | Whole Body Less Head | 0.815 | Standard Deviation 0.198 | Z-score |
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | Control Participants | Total Hip | 0.231 | Standard Deviation 0.170 | Z-score |
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | POI Participants | Total Hip | 0.370 | Standard Deviation 0.170 | Z-score |
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | Control Participants | Femoral Neck | 0.337 | Standard Deviation 0.195 | Z-score |
| Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neck | POI Participants | Femoral Neck | 0.556 | Standard Deviation 0.196 | Z-score |
| Change in Volumetric Bone Mineral Density (vBMD) at the Distal Radius as Measured by Peripheral Quantitative Computed Tomography (pQCT) | Control Participants | 3% trabecular volumetric BMD | -1.245 | Standard Deviation 14.484 | mg/mm^3 |
| Change in Volumetric Bone Mineral Density (vBMD) at the Distal Radius as Measured by Peripheral Quantitative Computed Tomography (pQCT) | POI Participants | 3% trabecular volumetric BMD | -5.415 | Standard Deviation 14.638 | mg/mm^3 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Participants | 9 | |
| Overall Study | STARTED | Primary Ovarian Insufficiency (POI) Participants | 10 | |
| Overall Study | COMPLETED | Control Participants | 8 | |
| Overall Study | COMPLETED | Primary Ovarian Insufficiency (POI) Participants | 8 | |
| Overall Study | NOT COMPLETED | Control Participants | 1 | |
| Overall Study | NOT COMPLETED | Primary Ovarian Insufficiency (POI) Participants | 2 |
Source ClinicalTrials.gov
Adverse events46
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 | Pain/irritation at patch site | Skin and subcutaneous tissue disorders | Control Participants | 0 | 9 | 0 |
| other | Pain/irritation at patch site | Skin and subcutaneous tissue disorders | POI Participants | 3 | 10 | 5 |
| other | Foot injury | Injury, poisoning and procedural complications | Control Participants | 0 | 9 | 0 |
| other | Foot injury | Injury, poisoning and procedural complications | POI Participants | 3 | 10 | 4 |
| other | Bronchitis | Infections and infestations | Control Participants | 0 | 9 | 0 |
| other | Bronchitis | Infections and infestations | POI Participants | 1 | 10 | 1 |
| other | Breast Lump | Reproductive system and breast disorders | Control Participants | 0 | 9 | 0 |
| other | Breast Lump | Reproductive system and breast disorders | POI Participants | 1 | 10 | 1 |
| other | Vasovagal Syncope | General disorders | Control Participants | 0 | 9 | 0 |
| other | Vasovagal Syncope | General disorders | POI Participants | 1 | 10 | 1 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Participants | 0 | 9 |
| Total, all-cause mortality | POI Participants | 0 | 10 |
| Total, other adverse events | Control Participants | 4 | 9 |
| Total, other adverse events | POI Participants | 8 | 10 |
| Total, serious adverse events | Control Participants | 0 | 9 |
| Total, serious adverse events | POI Participants | 1 | 10 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| POI Participants vs Control Participants: deaths from any cause | Trial comparisons |
| POI Participants vs Control Participants: serious adverse events | Trial comparisons |
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.
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