Trial · NCT03749109
Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
NCT03749109, Phase 2, Completed, Ferring Pharmaceuticals; results first posted 2022-09-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis. Trials, record NCT03749109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03749109
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
- NCT number
- NCT03749109
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Endometriosis
- Interventions
- Quinagolide 1080 µg, Placebo
- First posted
- 2018-11-21
- Last updated
- 2023-08-07
- Results first posted
- 2022-09-07
Source ClinicalTrials.gov
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis. |
| Secondary | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Secondary | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Secondary | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Secondary | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Secondary | Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Secondary | Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4. |
| Secondary | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | B\&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15. |
| Secondary | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) | Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes: * during the last menstrual cycle * during the menstrual period of the last menstrual cycle * during the non-menstrual period of the last menstrual cycle |
| Secondary | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months) | EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always. |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 registered outcomesOutcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Percentage of changes in the size | MEAN |
| SECONDARY | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Percentage of lesions | NUMBER |
| SECONDARY | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Percentage of subjects | NUMBER |
| SECONDARY | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Lesions | NUMBER |
| SECONDARY | Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, and 45 subjects in the DIE group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | score on a scale | MEAN |
| SECONDARY | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | score on a scale | MEAN |
| SECONDARY | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months) | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Score on a scale | MEAN |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group268
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Quinagolide 1080 µg | Endometrioma | -0.20 | Standard Error 4.34 | mm |
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Placebo | Endometrioma | -1.94 | Standard Error 4.48 | mm |
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Quinagolide 1080 µg | DIE | 2.41 | Standard Error 2.52 | mm |
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Placebo | DIE | -0.94 | Standard Error 2.03 | mm |
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Quinagolide 1080 µg | Adenomyosis | -3.10 | Standard Error 3.75 | mm |
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Placebo | Adenomyosis | -3.43 | Standard Error 3.87 | mm |
| Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Quinagolide 1080 µg | Endometrioma | 15.64 | Standard Deviation 70.12 | Percentage of changes in the size |
| Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Placebo | Endometrioma | -6.83 | Standard Deviation 44.46 | Percentage of changes in the size |
| Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Quinagolide 1080 µg | DIE | 7.67 | Standard Deviation 15.22 | Percentage of changes in the size |
| Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Placebo | DIE | 5.81 | Standard Deviation 37.73 | Percentage of changes in the size |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Quinagolide 1080 µg | 35 | |
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | COMPLETED | Quinagolide 1080 µg | 33 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Quinagolide 1080 µg | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events32
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 | Nausea | Gastrointestinal disorders | Quinagolide 1080 µg | 3 | 35 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 32 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Quinagolide 1080 µg | 2 | 35 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 1 | 32 | 1 |
| other | Rectal Haemorrhage | Gastrointestinal disorders | Quinagolide 1080 µg | 0 | 35 | 0 |
| other | Rectal Haemorrhage | Gastrointestinal disorders | Placebo | 2 | 32 | 4 |
| other | Fatigue | General disorders | Quinagolide 1080 µg | 1 | 35 | 1 |
| other | Fatigue | General disorders | Placebo | 2 | 32 | 2 |
| other | Peripheral swelling | General disorders | Quinagolide 1080 µg | 2 | 35 | 2 |
| other | Peripheral swelling | General disorders | Placebo | 1 | 32 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quinagolide 1080 µg | 0 | 35 |
| Total, all-cause mortality | Placebo | 0 | 32 |
| Total, other adverse events | Quinagolide 1080 µg | 20 | 35 |
| Total, other adverse events | Placebo | 20 | 32 |
| Total, serious adverse events | Quinagolide 1080 µg | 1 | 35 |
| Total, serious adverse events | Placebo | 0 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40188683 | DERIVED |
Source PubMed
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 |
|---|---|
| Quinagolide 1080 µg vs Placebo: deaths from any cause | Trial comparisons |
| Quinagolide 1080 µg vs Placebo: 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03749109
GET https://conductscience.org/api/trials/v1/NCT03749109/registered?page=2