SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
- Conditions
- Dysmenorrhea
- Interventions
- Registration Number
- NCT00511797
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 249
- Patients aged 20 years or older at obtaining informed consent
- Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment
- Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment
- Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol)
- Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
- Patients with undiagnosed abnormal vaginal bleeding
- Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), 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 prodrome (e.g. scintillating scotoma or star-shaped scintillation)
- Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis
- Patients who are regularly taking nutritional products that contain St. John's Wort
- Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening
- Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 1 tablet per day placebo for 28 days in each 28-day cycle DRSP 1 mg/EE 20 μg SH T04740B 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle DRSP 2 mg/EE 20 μg SH T04740F 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle DRSP 3 mg/EE 20 μg SH T00186DF 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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).
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).
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).
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.
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).
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).
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).
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.
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.
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.
Participants With Withdrawal Bleeding At Cycle 4 (28 days per cycle) Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Participants With Intracyclic Bleeding At Cycle 4 (28 days per cycle) Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
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).
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).
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.
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.
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.
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.