Trial · NCT00437658
Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis
NCT00437658, Phase 2, Completed, AbbVie; results first posted 2018-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis. Trials, record NCT00437658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00437658
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis
- NCT number
- NCT00437658
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 252 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Endometriosis
- Interventions
- Elagolix, Subcutaneous depot medroxyprogesterone acetate (DMPA-SC), Placebo to Elagolix, Placebo to DMPA-SC
- First posted
- 2007-02-21
- Last updated
- 2018-10-12
- Results first posted
- 2018-10-12
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 | Baseline and week 24 | Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24. |
| Primary | Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 | Baseline and week 24 | Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24. |
| Secondary | Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48 | Baseline and weeks 12 and 48 | Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model. |
| Secondary | Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48 | Baseline and weeks 12 and 48 | Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model. |
| Secondary | Change From Baseline in N-telopeptide at Weeks 12, 24 and 48 | Baseline and weeks 12, 24 and 48 | Blood samples to determine N-telopeptide concentrations were analyzed by a central laboratory using an enzyme-linked immunosorbent assay (ELISA). Change from baseline in N-telopeptide was analyzed using a one-way ANOVA model. |
| Secondary | Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24 | Baseline and week 24 | The CPSSS consists of 5 components that address dysmenorrhea (pain during menstruation), dyspareunia (painful intercourse), non-menstrual pelvic pain, pelvic tenderness, and pelvic induration (hardening). Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?". Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline. |
| Secondary | Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24 | Baseline and week 24 | The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?" Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline. |
| Secondary | Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time | Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48 | The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?". Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline. |
| Secondary | Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time | Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48 | The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?" Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline. |
| Secondary | Change From Baseline in Total CPSSS During the Treatment Period | Baseline and weeks 4, 8, 12, 16, 20, and 24 | The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination. The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning). Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 | Baseline and week 24 | Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at both time points | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 | Baseline and week 24 | Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at both time points | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48 | Baseline and weeks 12 and 48 | Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48 | Baseline and weeks 12 and 48 | Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in N-telopeptide at Weeks 12, 24 and 48 | Baseline and weeks 12, 24 and 48 | Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point | nM bone collagen equivalents (BCE) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24 | Baseline and week 24 | All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary visual analog scale (VAS) values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24 | Baseline and week 24 | All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary visual analog scale (VAS) values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time | Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48 | All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time | Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48 | All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Total CPSSS During the Treatment Period | Baseline and weeks 4, 8, 12, 16, 20, and 24 | All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group438
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 | Elagolix 150 mg QD | -0.11 | 95% Confidence Interval -0.70 to 0.48 | percent change | |
| Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 | Elagolix 75 mg BID | -1.29 | 95% Confidence Interval -1.85 to -0.74 | percent change | |
| Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 | DMPA-SC | -0.99 | 95% Confidence Interval -1.61 to -0.37 | percent change | |
| Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 | Elagolix 150 mg QD | -0.47 | 95% Confidence Interval -0.96 to 0.02 | percent change | |
| Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 | Elagolix 75 mg BID | -1.02 | 95% Confidence Interval -1.48 to -0.56 | percent change | |
| Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 | DMPA-SC | -1.29 | 95% Confidence Interval -1.80 to -0.77 | percent change | |
| Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48 | Elagolix 150 mg QD | Week 12 | -0.39 | 95% Confidence Interval -0.80 to 0.02 | percent change |
| Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48 | Elagolix 75 mg BID | Week 12 | -1.05 | 95% Confidence Interval -1.46 to -0.64 | percent change |
| Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48 | DMPA-SC | Week 12 | -0.57 | 95% Confidence Interval -0.98 to -0.15 | percent change |
| Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48 | Elagolix 150 mg QD | Week 48 | 0.20 | 95% Confidence Interval -0.57 to 0.96 | percent change |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (24 Weeks) | STARTED | Elagolix 150 mg QD | 84 | |
| Treatment Period (24 Weeks) | STARTED | Elagolix 75 mg BID | 84 | |
| Treatment Period (24 Weeks) | STARTED | DMPA-SC | 84 | |
| Treatment Period (24 Weeks) | Received Study Drug | Elagolix 150 mg QD | 84 | |
| Treatment Period (24 Weeks) | Received Study Drug | Elagolix 75 mg BID | 84 | |
| Treatment Period (24 Weeks) | Received Study Drug | DMPA-SC | 84 | |
| Treatment Period (24 Weeks) | COMPLETED | Elagolix 150 mg QD | 56 | |
| Treatment Period (24 Weeks) | COMPLETED | Elagolix 75 mg BID | 62 | |
| Treatment Period (24 Weeks) | COMPLETED | DMPA-SC | 51 | |
| Treatment Period (24 Weeks) | NOT COMPLETED | Elagolix 150 mg QD | 28 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events111
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 | ABDOMINAL DISTENSION | Gastrointestinal disorders | Elagolix 150 mg QD | 2 | 84 | 2 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Elagolix 75 mg BID | 0 | 84 | 0 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | DMPA-SC | 6 | 84 | 7 |
| other | DIARRHOEA | Gastrointestinal disorders | Elagolix 150 mg QD | 4 | 84 | 4 |
| other | DIARRHOEA | Gastrointestinal disorders | Elagolix 75 mg BID | 9 | 84 | 10 |
| other | DIARRHOEA | Gastrointestinal disorders | DMPA-SC | 8 | 84 | 10 |
| other | DYSPEPSIA | Gastrointestinal disorders | Elagolix 150 mg QD | 1 | 84 | 1 |
| other | DYSPEPSIA | Gastrointestinal disorders | Elagolix 75 mg BID | 5 | 84 | 7 |
| other | DYSPEPSIA | Gastrointestinal disorders | DMPA-SC | 3 | 84 | 3 |
| other | NAUSEA | Gastrointestinal disorders | Elagolix 150 mg QD | 16 | 84 | 21 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Elagolix 150 mg QD | 0 | 84 |
| Total, all-cause mortality | Elagolix 75 mg BID | 0 | 84 |
| Total, all-cause mortality | DMPA-SC | 0 | 84 |
| Total, other adverse events | Elagolix 150 mg QD | 63 | 84 |
| Total, other adverse events | Elagolix 75 mg BID | 59 | 84 |
| Total, other adverse events | DMPA-SC | 63 | 84 |
| Total, serious adverse events | Elagolix 150 mg QD | 3 | 84 |
| Total, serious adverse events | Elagolix 75 mg BID | 3 | 84 |
| Total, serious adverse events | DMPA-SC | 6 | 84 |
Source ClinicalTrials.gov
Papers0
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/NCT00437658
GET https://conductscience.org/api/trials/v1/NCT00437658/registered?page=2