Trial · NCT00909857
Effect on Primary Dysmenorrhea
NCT00909857, Phase 3, Completed, Bayer; results first posted 2012-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect on Primary Dysmenorrhea. Trials, record NCT00909857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00909857
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect on Primary Dysmenorrhea
- NCT number
- NCT00909857
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 507 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Primary Dysmenorrhea
- Interventions
- Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ethinyl estradiol, Levonorgestrel (Miranova), Placebo Match to SH T00658ID, Placebo Match to SH D593B
- First posted
- 2009-05-29
- Last updated
- 2015-08-24
- Other registries' IDs
- eudract:2008-005625-11
- Results first posted
- 2012-02-27
Source ClinicalTrials.gov
Registered outcomes68
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Secondary | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst) |
| Secondary | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Secondary | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period). |
| Secondary | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Secondary | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Secondary | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Secondary | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). |
| Secondary | Percentage of Participants Satisfied With Study Treatment | From cycle 1 to cycle 3 (28 days per cycle) | Participants were asked to express the degree of their satisfaction with study treatment. |
| Secondary | Number of Days With Bleeding or Spotting | From day 1 to day 90 | Bleeding/spotting episodes (day\[s\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 registered outcomesOutcomes68
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Scores on a scale | MEAN |
| SECONDARY | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Tablets | MEAN |
| SECONDARY | Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Tablets | MEAN |
| SECONDARY | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Satisfied With Study Treatment | From cycle 1 to cycle 3 (28 days per cycle) | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Percentage of participants | NUMBER |
| SECONDARY | Number of Days With Bleeding or Spotting | From day 1 to day 90 | Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure | Days | MEAN |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 outcomesResults by group230
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -4.6 | Standard Deviation 4.6 | Days | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | Ethinyl Estradiol, Levonorgestrel (Miranova) | -4.2 | Standard Deviation 4.2 | Days | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -10.6 | Standard Deviation 9.7 | Scores on a scale | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | Ethinyl Estradiol, Levonorgestrel (Miranova) | -10.0 | Standard Deviation 8.9 | Scores on a scale | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -4.0 | Standard Deviation 5.7 | Days | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | Ethinyl Estradiol, Levonorgestrel (Miranova) | -3.7 | Standard Deviation 5.7 | Days | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.3 | Standard Deviation 2.6 | Days | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.1 | Standard Deviation 2.0 | Days | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -6.2 | Standard Deviation 14.8 | Tablets | |
| Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | Ethinyl Estradiol, Levonorgestrel (Miranova) | -6.6 | Standard Deviation 12.3 | Tablets |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 253 | |
| Overall Study | STARTED | Ethinyl Estradiol, Levonorgestrel (Miranova) | 254 | |
| Overall Study | Treated | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 234 | |
| Overall Study | Treated | Ethinyl Estradiol, Levonorgestrel (Miranova) | 230 | |
| Overall Study | COMPLETED | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 217 | |
| Overall Study | COMPLETED | Ethinyl Estradiol, Levonorgestrel (Miranova) | 209 | |
| Overall Study | NOT COMPLETED | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 36 | |
| Overall Study | NOT COMPLETED | Ethinyl Estradiol, Levonorgestrel (Miranova) | 45 |
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 | Dental caries | Gastrointestinal disorders | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5 | 234 | 10 |
| other | Dental caries | Gastrointestinal disorders | Ethinyl Estradiol, Levonorgestrel (Miranova) | 2 | 230 | 7 |
| other | Nausea | Gastrointestinal disorders | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2 | 234 | 2 |
| other | Nausea | Gastrointestinal disorders | Ethinyl Estradiol, Levonorgestrel (Miranova) | 5 | 230 | 6 |
| other | Inflammation | General disorders | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 7 | 234 | 7 |
| other | Inflammation | General disorders | Ethinyl Estradiol, Levonorgestrel (Miranova) | 3 | 230 | 3 |
| other | Influenza | Infections and infestations | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2 | 234 | 2 |
| other | Influenza | Infections and infestations | Ethinyl Estradiol, Levonorgestrel (Miranova) | 5 | 230 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4 | 234 | 6 |
| other | Upper respiratory tract infection | Infections and infestations | Ethinyl Estradiol, Levonorgestrel (Miranova) | 7 | 230 | 10 |
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 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | ||
| Total, all-cause mortality | Ethinyl Estradiol, Levonorgestrel (Miranova) | ||
| Total, other adverse events | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 131 | 234 |
| Total, other adverse events | Ethinyl Estradiol, Levonorgestrel (Miranova) | 122 | 230 |
| Total, serious adverse events | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2 | 234 |
| Total, serious adverse events | Ethinyl Estradiol, Levonorgestrel (Miranova) | 2 | 230 |
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 |
|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) vs Ethinyl Estradiol, Levonorgestrel (Miranova): 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.
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