Trial · NCT00360490
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) | Baseline and up to 6 months | The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase. |
| Primary | Percentage of Patients With Successful Treatment | At 6 months | End-of-study MBL \< 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success. |
| Secondary | Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | Baseline and up to 6 months | The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100. |
| Secondary | Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | Baseline and up to 3 months | The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase. |
| Secondary | Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | Baseline and up to 3 months | The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100. |
| Secondary | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | Baseline and up to 6 months | |
| Secondary | Total Number of Bleeding Days | Baseline and up to 6 months | In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. |
| Secondary | Total Number of Spotting and Bleeding Days | Baseline and up to 6 months | In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. |
| Secondary | Total Number of Spotting Days | Baseline and up to 6 months | In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. |
| Secondary | Total Number of Bleeding Episodes | Baseline and up to 6 months | A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. |
| Secondary | Percent Change in Hemoglobin | Baseline and up to 6 months | |
| Secondary | Percent Change in Hematocrit | Baseline and up to 6 months | |
| Secondary | Percent Change in Serum Ferritin | Baseline and up to 6 months | |
| Secondary | Percentage of Patients With Improvement in the Investigator Global Assessment Scale | Up to 6 months | "Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse' |
| Secondary | Percentage of Patients With Improvement in the Patients Overall Assessment Scale | Up to 6 months | "Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00360490/registered