Trial · NCT00511797
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Dysmenorrheal Score at Final Evaluation | Baseline and up to 4 Cycles (28 days per cycle) | Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.) |
| Secondary | Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4 | Baseline and up to 4 Cycles (28 days per cycle) | Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. |
| Secondary | Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4 | Cycle 4 (28 days per cycle) | Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4 | Cycle 4 (28 days per cycle) | Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Number of Participants With Severity of Headache During Menstruation at Cycle 4 | Cycle 4 (28 days per cycle) | Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4 | Cycle 4 (28 days per cycle) | Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4 | Cycle 4 (28 days per cycle) | Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4 | From baseline up to Cycle 4 (28 days per cycle) | VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced). |
| Secondary | Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4 | Cycle 4 (28 days per cycle) | VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced). |
| Secondary | Change From Baseline in Endometrial Thickness After 4-cycle Treatment | From baseline to Cycle 4 (28 days per cycle) | Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer. |
| Secondary | Number of Bleeding / Spotting Episodes | For the first 90 days | Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity. |
| Secondary | Number of Bleeding / Spotting Days | For the first 90 days | Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity. |
| Secondary | Participants With Withdrawal Bleeding | At Cycle 4 (28 days per cycle) | Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. |
| Secondary | Participants With Intracyclic Bleeding | At Cycle 4 (28 days per cycle) | Intracyclic bleedings were defined as bleedings while a participant takes active drugs. |
| Secondary | Participants With Non-heavy Intracyclic Bleeding | At Cycle 4 (28 days per cycle) | Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). |
| Secondary | Participants With Non-heavy Withdrawal Bleeding | At Cycle 4 (28 dyas per cycle) | Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). |
| Secondary | Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment | From baseline to Cycle 4 (28 days per cycle) | CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. |
| Secondary | Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment | From baseline to Cycle 4 (28 days per cycle) | CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation. |
| Secondary | Change From Baseline in Serum Estradiol Level After 4-cycle Treatment | From baseline to Cycle 4 (28 days per cycle) | Estradiol is a predominant sex hormone that presents in female. |
| Secondary | Change From Baseline in Serum Progesterone Level at Cycle 4 | From baseline to Cycle 4 (28 days per cycle) | Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc. |
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.
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GET https://conductscience.org/api/trials/v1/NCT00511797/registered