A Phase 3 interventional study of Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring and Placebo vaginal ring in Moderate to Severe Primary Dysmenorrhea, sponsored by Organon and Co. Terminated. Open to female participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the etonogestrel (ENG) + 17β-estradiol (E2) vaginal ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. In addition, this study will assess the safety and tolerability of the ENG-E2 vaginal rings. 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.
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
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Exclusion Criteria:
Participants will receive 4 cycles (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg. Each cycle will consist of 21 days of vaginal ring use followed by 7 ring-free days.
Drug: Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring · Drug: Ibuprofen
Participants will receive 4 cycles (or 6 cycles if also participating in the extension) of placebo. Each cycle will consist of 21 days of placebo vaginal ring use followed by 7 ring-free days.
Drug: Placebo vaginal ring · Drug: Ibuprofen
Up to 4 cycles (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg administered intravaginally. Each cycle will consist of 21 days of vaginal ring use followed by 7 ring-free days.
Also known as: MK-8342B
Up to 4 cycles (or 6 cycles if also participating in the extension) of placebo administered intravaginally. Each cycle will consist of 21 days of placebo vaginal ring use followed by 7 ring-free days.
Ibuprofen tablets, to be taken orally, will be provided for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may take 400 mg every 4 hours as needed for pelvic pain/cramping, or as instructed by their physician according to local labeling for relief of menstrual pain.
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.
Time frame: 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.
Time frame: Up to approximately 158 days
Number of Participants Who Discontinued 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 to an AE is presented.
Time frame: Up to approximately 128 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 Ibuprofen Tablet Intake 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.
Time frame: Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant
Change From Baseline in 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.
Time frame: Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant
| Milestone | ENG-E2 125 μg/300 μg | Placebo |
|---|---|---|
| Started | 13 | 12 |
| Treated | 13 | 11 |
| Completed | 0 | 0 |
| Not completed | 13 | 12 |
| Withdrew: Pregnancy | 0 | 1 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Study terminated by sponsor | 9 | 10 |
| Withdrew: Subject moved | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
No measurements were reported for this outcome.
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.
| Participants | ENG-E2 125 μg/300 μg | Placebo |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 1 | 2 |
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 to an AE is presented.
| Participants | ENG-E2 125 μg/300 μg | Placebo |
|---|---|---|
| Number of Participants Who Discontinued Treatment Due to an AE | 0 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Up to approximately 158 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ENG-E2 125 Microgram/300 Microgram | — | 0/13 (0%) | 1/13 (7.7%) |
| Placebo | — | 0/11 (0%) | 2/11 (18.2%) |
| Event | ENG-E2 125 Microgram/300 Microgram | Placebo |
|---|---|---|
| Vomiting in pregnancyPregnancy, puerperium and perinatal conditions | 0/13 | 1/11 |
| Vulvovaginal discomfortReproductive system and breast disorders | 0/13 | 1/11 |
| Mood swingsPsychiatric disorders | 1/13 | 0/11 |
| Age, Continuous(Years) | ENG-E2 125 μg/300 μg | Placebo | Total |
|---|---|---|---|
| Mean | 27 ± 7 | 29 ± 6 | 28 ± 6 |
| Sex: Female, Male(Participants) | ENG-E2 125 μg/300 μg | Placebo | Total |
|---|---|---|---|
| Female | 13 | 12 | 25 |
| Male | 0 | 0 | 0 |
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Organon and Co