Clinical trial NCT00461305: Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
Official title: A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea
Intracyclic bleeding
Drospirenone (DRSP)
Ethinylestradiol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 420
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Intracyclic Bleeding at Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
Secondary outcomes:
measure: Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
timeFrame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
measure: Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
timeFrame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
measure: Distribution of Total Dysmenorrhea Score at Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Distribution of Total Dysmenorrhea Score at Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Distribution of Severity of Lumbago During Menstruation at Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Distribution of Severity of Lumbago During Menstruation at Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Distribution of Severity of Headache During Menstruation at Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Distribution of Severity of Headache During Menstruation at Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6
timeFrame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
measure: Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13
timeFrame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
measure: Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6
timeFrame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
measure: Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13
timeFrame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
measure: Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Number of Any Bleeding Days From Cycle 1 to Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Number of Any Bleeding Days From Cycle 1 to Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
timeFrame: Up to Cycle 6 (168 days) with 28 days per cycle
measure: Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
timeFrame: Up to Cycle 13 (364 days) with 28 days per cycle
measure: Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6
timeFrame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
measure: Change in Serum CA-125 From Baseline to Cycle 13
timeFrame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
measure: Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6
timeFrame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
measure: Change in Serum CRP From Baseline to Cycle 13
timeFrame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Maebashi
country: Japan
state: Gunma
city: Takasaki
country: Japan
state: Gunma
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Yamato
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Toyonaka
country: Japan
state: Osaka
city: Chuo-ku
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Machida
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Suginami-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Osaka
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: