Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

Bayer420 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

420

Conditions

Dysmenorrhea

Interventions

DRSP 3 mg/EE 20 µg (13 cycles)DRUG

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)DRUG

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)

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (26)

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

Number of Participants With Intracyclic Bleeding at Cycle 6

Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Secondary Outcomes

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.

Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle

Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13

Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle

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.

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Distribution of Total Dysmenorrhea Score at Cycle 13

Data from ClinicalTrials.gov

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Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Maebashi, Gunma, Japan

Unnamed facility

Takasaki, Gunma, Japan

Unnamed facility

Kobe, Hyōgo, Japan

Unnamed facility

Nishinomiya, Hyōgo, Japan

Unnamed facility

Yamato, Kanagawa, Japan

Unnamed facility

Yokohama, Kanagawa, Japan

Unnamed facility

Sendai, Miyagi, Japan

...and 16 more locations

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.

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Distribution of Severity of Lumbago During Menstruation at Cycle 13

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Distribution of Severity of Headache During Menstruation at Cycle 13

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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.

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

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.

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle

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).

Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle

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).

Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle

Number of Any Bleeding Episodes From Cycle 1 to Cycle 6

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

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).

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

Number of Any Bleeding Days From Cycle 1 to Cycle 6

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

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).

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6

Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13

Intracyclic bleedings were defined as bleedings while a participant takes active tablets.

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6

Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13

Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

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).

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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).

Time frame: Up to Cycle 6 (168 days) with 28 days per cycle

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).

Time frame: Up to Cycle 13 (364 days) with 28 days per cycle

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.

Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle

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.

Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle

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.

Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle

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.

Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle