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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00461305
Other study ID # 91616
Secondary ID 310284
Status Completed
Phase Phase 2/Phase 3
First received April 17, 2007
Last updated January 22, 2013
Start date February 2007
Est. completion date August 2009

Study information

Verified date January 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety


Description:

The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.

The trial is sponsored by Bayer Yakuhin, Ltd.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date August 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients aged 20 years or older at obtaining informed consent

- Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment

- Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Exclusion Criteria:

- Patients with ovarian chocolate cysts

- Patients with fibroid needed to be treated

- Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer

- Patients with undiagnosed abnormal vaginal bleeding

- Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases

- Patients aged 35 years or older who smoke at least 15 cigarettes per day

- Patients with migraine accompanied by prodromata

- Patients with pulmonary hypertension or valvular heart disease

- Patients who are regularly taking nutritional products that contain St. John's Wort

- Patients who underwent surgical treatment for endometriosis within 2 months prior to screening

- Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
DRSP 3 mg/EE 20 µg (13 cycles)
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
DRSP 3 mg/EE 30 µg (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Intracyclic Bleeding at Cycle 6 Intracyclic bleedings were defined as bleedings while a participant takes active tablets. Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 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). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. From baseline up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 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). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. From baseline up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Distribution of Total Dysmenorrhea Score at Cycle 6 Total dysmenorrhea 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. Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Distribution of Total Dysmenorrhea Score at Cycle 13 Total dysmenorrhea 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. Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 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). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 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). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Distribution of Severity of Lumbago During Menstruation at Cycle 6 Severity of lumbago 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). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Distribution of Severity of Lumbago During Menstruation at Cycle 13 Severity of lumbago 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). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Distribution of Severity of Headache During Menstruation at Cycle 6 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). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Distribution of Severity of Headache During Menstruation at Cycle 13 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). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 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). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 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). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 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. Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 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. Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6 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). From baseline up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13 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). From baseline up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6 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). From baseline up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13 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). From baseline up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Number of Any Bleeding Days From Cycle 1 to Cycle 6 Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Number of Any Bleeding Days From Cycle 1 to Cycle 13 Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 Intracyclic bleedings were defined as bleedings while a participant takes active tablets. Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 Intracyclic bleedings were defined as bleedings while a participant takes active tablets. Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). Up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). Up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6 CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. From baseline up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Change in Serum CA-125 From Baseline to Cycle 13 CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. From baseline up to Cycle 13 (364 days) with 28 days per cycle No
Secondary Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6 CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation. From baseline up to Cycle 6 (168 days) with 28 days per cycle No
Secondary Change in Serum CRP From Baseline to Cycle 13 CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation. From baseline up to Cycle 13 (364 days) with 28 days per cycle No
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