Trial · NCT00474851
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
NCT00474851, Phase 2, Completed, Boston Children's Hospital; results first posted 2015-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial. Trials, record NCT00474851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00474851
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
- NCT number
- NCT00474851
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Endometriosis
- Interventions
- Norethindrone acetate + estrogens, norethindrone acetate + placebo
- First posted
- 2007-05-17
- Last updated
- 2015-03-30
- Results first posted
- 2015-03-30
- Limitations and caveats
- Sample of skeletally mature young women; Measurements of aBMD are two-dimensional and do not yield information regarding skeletal strength or microarchitecture
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Mineral Density | Baseline to 12 months | Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial |
| Secondary | Total Body Bone Mineral Content (BMC) | Baseline to 12 months |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bone Mineral Density | Baseline to 12 months | g/cm^2 | MEAN | |
| SECONDARY | Total Body Bone Mineral Content (BMC) | Baseline to 12 months | g | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bone Mineral Density | Intervention Group | 0.01 | Standard Error 0.006 | g/cm^2 | |
| Bone Mineral Density | Placebo Group | -0.11 | Standard Error 0.006 | g/cm^2 | |
| Total Body Bone Mineral Content (BMC) | Intervention Group | 37 | Standard Error 10 | g | |
| Total Body Bone Mineral Content (BMC) | Placebo Group | 15 | Standard Error 11 | g |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Group | 26 | |
| Overall Study | STARTED | Placebo Group | 27 | |
| Overall Study | Completed Baseline | Intervention Group | 25 | |
| Overall Study | Completed Baseline | Placebo Group | 26 | |
| Overall Study | COMPLETED | Intervention Group | 18 | |
| Overall Study | COMPLETED | Placebo Group | 16 | |
| Overall Study | NOT COMPLETED | Intervention Group | 8 | |
| Overall Study | NOT COMPLETED | Placebo Group | 11 |
Source ClinicalTrials.gov
Adverse events16
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 | Myalgias/arthralgias | Musculoskeletal and connective tissue disorders | Intervention Group | 2 | 25 | 2 |
| other | Myalgias/arthralgias | Musculoskeletal and connective tissue disorders | Placebo Group | 2 | 26 | 2 |
| other | Pelvic pain | Reproductive system and breast disorders | Intervention Group | 8 | 25 | 11 |
| other | Pelvic pain | Reproductive system and breast disorders | Placebo Group | 8 | 26 | 8 |
| other | Vaginal bleeding | Reproductive system and breast disorders | Intervention Group | 3 | 25 | 3 |
| other | Vaginal bleeding | Reproductive system and breast disorders | Placebo Group | 2 | 26 | 2 |
| other | Mood swings | Psychiatric disorders | Intervention Group | 2 | 25 | 2 |
| other | Mood swings | Psychiatric disorders | Placebo Group | 1 | 26 | 1 |
| serious | Hospitalization for pelvic/abdominal pain | Reproductive system and breast disorders | Intervention Group | 3 | 25 | 4 |
| serious | Hospitalization for pelvic/abdominal pain | Reproductive system and breast disorders | Placebo Group | 0 | 26 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Group | ||
| Total, all-cause mortality | Placebo Group | ||
| Total, other adverse events | Intervention Group | 15 | 25 |
| Total, other adverse events | Placebo Group | 13 | 26 |
| Total, serious adverse events | Intervention Group | 8 | 25 |
| Total, serious adverse events | Placebo Group | 5 | 26 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intervention Group vs Placebo Group: serious adverse events |
Source 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00474851
GET https://conductscience.org/api/trials/v1/NCT00474851/registered