SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

Phase 3CompletedNCT00511797

Bayer249 enrolled

Overview

The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

249

Conditions

Dysmenorrhea

Interventions

SH T04740BDRUG

Drospirenone 1mg/EE 20µg (ß-CDC)

SH T00186DFDRUG

Drospirenone 3 mg/EE 20µg (ß-CDC)

SH T04740FDRUG

Drospirenone 2 mg/EE 20µg (ß-CDC)

Placebo

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 (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 Exclusion Criteria: * 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)

Locations (12)

Unnamed facility

Maebashi, Gunma, Japan

Unnamed facility

Kobe, Hyōgo, Japan

Unnamed facility

Nishinomiya, Hyōgo, Japan

Unnamed facility

Yokohama, Kanagawa, Japan

Outcomes

Primary Outcomes

Change From Baseline in Total Dysmenorrheal Score at Final Evaluation

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.)

Time frame: Baseline and up to 4 Cycles (28 days per cycle)

Secondary Outcomes

Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4

Time frame: Baseline and up to 4 Cycles (28 days per cycle)

Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4

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: Cycle 4 (28 days per cycle)

Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4

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).

Time frame: Cycle 4 (28 days per cycle)

Number of Participants With Severity of Headache During Menstruation at Cycle 4

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).

Data from ClinicalTrials.gov

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Unnamed facility

Kyoto, Kyoto, Japan

Unnamed facility

Sendai, Miyagi, Japan

Unnamed facility

Osaka, Osaka, Japan

Unnamed facility

Chuo-ku, Tokyo, Japan

Unnamed facility

Hachiōji, Tokyo, Japan

Unnamed facility

Setagaya-ku, Tokyo, Japan

...and 2 more locations

Time frame: Cycle 4 (28 days per cycle)

Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4

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: Cycle 4 (28 days per cycle)

Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4

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: Cycle 4 (28 days per cycle)

Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4

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 4 (28 days per cycle)

Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4

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: Cycle 4 (28 days per cycle)

Change From Baseline in Endometrial Thickness After 4-cycle Treatment

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.

Time frame: From baseline to Cycle 4 (28 days per cycle)

Number of Bleeding / Spotting Episodes

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.

Time frame: For the first 90 days

Number of Bleeding / Spotting Days

Time frame: For the first 90 days

Participants With Withdrawal Bleeding

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

Time frame: At Cycle 4 (28 days per cycle)

Participants With Intracyclic Bleeding

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

Time frame: At Cycle 4 (28 days per cycle)

Participants With Non-heavy Intracyclic Bleeding

Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).

Time frame: At Cycle 4 (28 days per cycle)

Participants With Non-heavy Withdrawal Bleeding

Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).

Time frame: At Cycle 4 (28 dyas per cycle)

Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment

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 to Cycle 4 (28 days per cycle)

Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment

CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.

Time frame: From baseline to Cycle 4 (28 days per cycle)

Change From Baseline in Serum Estradiol Level After 4-cycle Treatment

Estradiol is a predominant sex hormone that presents in female.

Time frame: From baseline to Cycle 4 (28 days per cycle)

Change From Baseline in Serum Progesterone Level at Cycle 4

Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.

Time frame: From baseline to Cycle 4 (28 days per cycle)