Trial · NCT00754065
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
NCT00754065, Phase 3, Completed, Bayer; results first posted 2012-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada). Trials, record NCT00754065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00754065
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
- NCT number
- NCT00754065
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 409 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Contraception
- Interventions
- Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ortho Tri Cyclen Lo
- First posted
- 2008-09-17
- Last updated
- 2024-11-20
- Results first posted
- 2012-08-28
Source ClinicalTrials.gov
Registered outcomes117
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6 | Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle) | Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). |
| Secondary | The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication | From Baseline to Cycle 6 (28 days per Cycle) | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived. |
| Secondary | The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication | From Baseline to Cycle 13 (28 days per Cycle) | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived. |
| Secondary | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 | Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle) | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. 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: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst). |
| Secondary | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 | Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle) | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. 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: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst). |
| Secondary | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 | Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle) | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. 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: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst). |
| Secondary | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 | Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle) | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. 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: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst). |
| Secondary | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM | From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle) | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). 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. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group. |
| Secondary | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM | From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle) | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). 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. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group. |
| Secondary | Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 | Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle) | Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 registered outcomesOutcomes117
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6 | Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle) | All participants in Full Analysis Set (FAS) with assessment for this outcome measure | mm | MEAN |
| SECONDARY | The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication | From Baseline to Cycle 6 (28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Tablets | MEAN |
| SECONDARY | The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication | From Baseline to Cycle 13 (28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Tablets | MEAN |
| SECONDARY | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 | Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 | Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 | Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 | Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM | From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM | From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle) | All participants in FAS with assessment for this outcome measure | Days | MEAN |
| SECONDARY | Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 | Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle) | All participants in FAS with assessment for this outcome measure | mm | MEAN |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 outcomesResults by group382
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 43.05 | Standard Deviation 23.58 | mm | |
| The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6 | Ortho Tri-Cyclen Lo | 34.97 | Standard Deviation 25.90 | mm | |
| The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Days 1-21 | -1.6 | Standard Deviation 9.9 | Tablets |
| The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication | Ortho Tri-Cyclen Lo | Days 1-21 | -3.0 | Standard Deviation 10.3 | Tablets |
| The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Days 22-28 | -5.8 | Standard Deviation 7.5 | Tablets |
| The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication | Ortho Tri-Cyclen Lo | Days 22-28 | -4.6 | Standard Deviation 8.0 | Tablets |
| The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Days 1-21 | -2.3 | Standard Deviation 8.3 | Tablets |
| The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication | Ortho Tri-Cyclen Lo | Days 1-21 | -3.5 | Standard Deviation 12.0 | Tablets |
| The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Days 22-28 | -5.3 | Standard Deviation 7.6 | Tablets |
| The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication | Ortho Tri-Cyclen Lo | Days 22-28 | -5.2 | Standard Deviation 8.9 | Tablets |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 results by groupParticipant flow10
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) | 203 | |
| Overall Study | STARTED | Ortho Tri-Cyclen Lo | 206 | |
| Overall Study | Participants Received Treatment | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 191 | |
| Overall Study | Participants Received Treatment | Ortho Tri-Cyclen Lo | 204 | |
| Overall Study | Cycle 6 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 141 | |
| Overall Study | Cycle 6 | Ortho Tri-Cyclen Lo | 153 | |
| Overall Study | COMPLETED | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 122 | |
| Overall Study | COMPLETED | Ortho Tri-Cyclen Lo | 126 | |
| Overall Study | NOT COMPLETED | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 81 | |
| Overall Study | NOT COMPLETED | Ortho Tri-Cyclen Lo | 80 |
Source ClinicalTrials.gov
Adverse events98
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 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 28 | 191 | |
| other | Abdominal distension | Gastrointestinal disorders | Ortho Tri-Cyclen Lo | 35 | 204 | |
| other | Abdominal pain | Gastrointestinal disorders | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6 | 191 | |
| other | Abdominal pain | Gastrointestinal disorders | Ortho Tri-Cyclen Lo | 4 | 204 | |
| other | Constipation | Gastrointestinal disorders | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3 | 191 | |
| other | Constipation | Gastrointestinal disorders | Ortho Tri-Cyclen Lo | 5 | 204 | |
| other | Diarrhoea | Gastrointestinal disorders | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5 | 191 | |
| other | Diarrhoea | Gastrointestinal disorders | Ortho Tri-Cyclen Lo | 2 | 204 | |
| other | Nausea | Gastrointestinal disorders | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 27 | 191 | |
| other | Nausea | Gastrointestinal disorders | Ortho Tri-Cyclen Lo | 30 | 204 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 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 | Ortho Tri-Cyclen Lo | ||
| Total, other adverse events | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 154 | 191 |
| Total, other adverse events | Ortho Tri-Cyclen Lo | 159 | 204 |
| Total, serious adverse events | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2 | 191 |
| Total, serious adverse events | Ortho Tri-Cyclen Lo | 5 | 204 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23638631 | RESULT |
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 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 Ortho Tri-Cyclen Lo: 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00754065
GET https://conductscience.org/api/trials/v1/NCT00754065/registered?page=2