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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004326-34 | EudraCT Number |
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Study terminated by Sponsor as a result of a business decision to discontinue the development program for MK-8342B for reasons unrelated to safety or efficacy.
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The purpose of this study was to evaluate the efficacy of the etonogestrel (ENG) + 17β-estradiol (E2) (MK-8342B) vaginal ring compared to placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. This study was also to assess the safety and tolerability of the ENG-E2 vaginal rings over 4 treatment cycles. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal ring results in a greater proportion of participants with a ≥3-point reduction in peak pelvic pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at Treatment Cycle 2 as compared to baseline.
The cramping window for each participant was to be defined as a 4-day time interval that began the day prior to initiation of each cyclic bleeding episode (spontaneous menses or hormone withdrawal bleeding) and continued until the third bleeding day (inclusive). An external committee of blinded independent reviewers was to determine the 4-day cramping window for each participant so that analysis of the efficacy data could be conducted. The study was terminated early due to a business decision by the Sponsor to discontinue product development for reasons unrelated to safety or efficacy outcomes. Due to the early study termination, the blinded independent review committee that was supposed to determine the 4-day cramping windows for data analysis was not assembled; thus cramping windows were not determined. Without defined cramping windows, the efficacy outcome measures for this study could not be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENG 125 μg + E2 300 μg (MK-8342B) | Experimental | Participants received up to 4 cycles of etonogestrel-17β estradiol (ENG-E2) at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days. |
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| Placebo | Placebo Comparator | Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENG 125 μg + E2 300 μg vaginal ring (MK-8342B) | Drug | Medicated vaginal ring |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the cramping window of the cycle and the total number of ibuprofen tablets taken was to be based on the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and no increase in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented. | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented. | Up to approximately 126 days |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due an AE is presented. | Up to approximately 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2 | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps). The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the 4-day cramping window of the cycle. The baseline peak pelvic pain score was to be defined as the mean value of the 2 peak pelvic pain scores during the cramping window of each of the 2 menstruations during the screening period. The change from baseline in peak pelvic pain score at Treatment Cycle 2 was to be presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | ENG 125 μg + E2 300 μg (MK-8342B) | Participants received up to 4 cycles of etonogestrel-17β-estradiol (ENG-E2) at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo vaginal ring | Drug | Placebo vaginal ring |
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| Ibuprofen | Drug | Ibuprofen 400-mg tablets, to be taken orally, were provided to the participants for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may have taken 400 mg every 4 hours as needed for pelvic pain/cramping. |
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| Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
| Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2 | Participants were asked to indicate how much pain or cramps limited their physical, work/school and social/leisure activities and over the previous 24 hours. The level of negative impact of dysmenorrhea on daily life was scored on a 5-point scale (0=Not at all to 4=Extremely impacted). For each of the 3 impact items, the baseline score was to be defined as the mean value obtained from the 2 menstruations during the screening period. The change from baseline to Treatment Cycle 2 in the number of days during the cramping window with no impact of dysmenorrhea (score = 0) on each of the following items was to be presented: work/school, physical activities and leisure/social activities. | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
| Percentage of Participants With Pelvic Pain Score of "0" or "1" and no Use of Ibuprofen Tablets at Treatment Cycle 2 | Participants were asked to rate their worst pain or cramps on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The percentage of participants with no or minimal pelvic pain (score of "0" or "1") and no use of ibuprofen at Treatment Cycle 2 was to be presented. | Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
| Percentage of Participants With ≥3-point Reduction in Peak Pelvic Pain Score and a Decrease in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and a decrease in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented. | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
| Change From Baseline in the Mean Pelvic Pain Score at Treatment Cycle 2 | The mean pelvic pain score was to be calculated as the mean of the highest scores for pelvic pain observed within the 4-day cramping window of the screening or treatment cycle. The baseline mean pelvic pain score was to be defined as the mean value of the 2 mean pelvic pain scores of the 2 menstruations during the screening period. The change from baseline in mean pelvic pain score at Treatment Cycle 2 was to be presented. | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ENG 125 μg + E2 300 μg (MK-8342B) | Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days. |
| BG001 | Placebo | Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the cramping window of the cycle and the total number of ibuprofen tablets taken was to be based on the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and no increase in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented. | The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed. | Posted | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
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| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented. | The population consisted of all participants in whom a vaginal ring was inserted. | Posted | Number | Participants | Up to approximately 126 days |
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| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due an AE is presented. | The population consisted of all participants in whom a vaginal ring was inserted. | Posted | Number | Participants | Up to approximately 112 days |
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| Secondary | Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2 | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps). The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the 4-day cramping window of the cycle. The baseline peak pelvic pain score was to be defined as the mean value of the 2 peak pelvic pain scores during the cramping window of each of the 2 menstruations during the screening period. The change from baseline in peak pelvic pain score at Treatment Cycle 2 was to be presented. | The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed. | Posted | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
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| Secondary | Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2 | Participants were asked to indicate how much pain or cramps limited their physical, work/school and social/leisure activities and over the previous 24 hours. The level of negative impact of dysmenorrhea on daily life was scored on a 5-point scale (0=Not at all to 4=Extremely impacted). For each of the 3 impact items, the baseline score was to be defined as the mean value obtained from the 2 menstruations during the screening period. The change from baseline to Treatment Cycle 2 in the number of days during the cramping window with no impact of dysmenorrhea (score = 0) on each of the following items was to be presented: work/school, physical activities and leisure/social activities. | The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed. | Posted | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
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| Secondary | Percentage of Participants With Pelvic Pain Score of "0" or "1" and no Use of Ibuprofen Tablets at Treatment Cycle 2 | Participants were asked to rate their worst pain or cramps on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The percentage of participants with no or minimal pelvic pain (score of "0" or "1") and no use of ibuprofen at Treatment Cycle 2 was to be presented. | The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during Treatment Cycle 2. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed. | Posted | Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
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| Secondary | Percentage of Participants With ≥3-point Reduction in Peak Pelvic Pain Score and a Decrease in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and a decrease in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented. | The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed. | Posted | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
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| Secondary | Change From Baseline in the Mean Pelvic Pain Score at Treatment Cycle 2 | The mean pelvic pain score was to be calculated as the mean of the highest scores for pelvic pain observed within the 4-day cramping window of the screening or treatment cycle. The baseline mean pelvic pain score was to be defined as the mean value of the 2 mean pelvic pain scores of the 2 menstruations during the screening period. The change from baseline in mean pelvic pain score at Treatment Cycle 2 was to be presented. | The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed. | Posted | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant |
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Up to 30 days after last dose of study treatment (Up to approximately 126 days)
The population consisted of all participants in whom a vaginal ring was inserted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENG 125 μg + E2 300 μg (MK-8342B) | Participants received up to 4 cycles of ENG-E2 at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days. | 0 | 9 | 0 | 9 | ||
| EG001 | Placebo | Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days. | 0 | 9 | 1 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000071063 | Endoglin |
| D003274 | Contraceptive Devices, Female |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Male |
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Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days. |
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| Units | Counts |
|---|---|
| Participants |
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| OG001 |
| Placebo |
Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days. |
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