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

Purpose

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

Condition	Intervention	Phase
Dysmenorrhea	Drug: SH T04740B Drug: SH T00186DF Drug: SH T04740F Drug: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Double-blind, Randomized, Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.

Resource links provided by NLM:

MedlinePlus related topics: Menstruation Nausea and Vomiting Pelvic Pain

Drug Information available for: Ethinyl Estradiol Drospirenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change From Baseline in Total Dysmenorrheal Score at Final Evaluation [ Time Frame: Baseline and up to 4 Cycles (28 days per cycle) ] [ Designated as safety issue: No ]
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:

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) ] [ Designated as safety issue: No ]
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 Lower Abdominal Pain During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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).
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: From baseline up to Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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).
Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: For the first 90 days ] [ Designated as safety issue: No ]
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 [ Time Frame: For the first 90 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Participants With Intracyclic Bleeding [ Time Frame: At Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
Participants With Non-heavy Intracyclic Bleeding [ Time Frame: At Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Participants With Non-heavy Withdrawal Bleeding [ Time Frame: At Cycle 4 (28 dyas per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
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 [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
Estradiol is a predominant sex hormone that presents in female.
Change From Baseline in Serum Progesterone Level at Cycle 4 [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ] [ Designated as safety issue: No ]
Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.

Enrollment:	249
Study Start Date:	July 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DRSP 1 mg/EE 20 μg 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	Drug: SH T04740B Drospirenone 1mg/EE 20µg (ß-CDC)
Experimental: DRSP 2 mg/EE 20 μg 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	Drug: SH T04740F Drospirenone 2 mg/EE 20µg (ß-CDC)
Experimental: DRSP 3 mg/EE 20 μg 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	Drug: SH T00186DF Drospirenone 3 mg/EE 20µg (ß-CDC)
Placebo Comparator: Placebo 1 tablet per day placebo for 28 days in each 28-day cycle	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511797

Locations

Japan

Maebashi, Gunma, Japan, 371-0024

Kobe, Hyogo, Japan, 650-0021

Nishinomiya, Hyogo, Japan, 663-8204

Yokohama, Kanagawa, Japan, 231-0861

Sendai, Miyagi, Japan, 981-0933

Chuo-ku, Tokyo, Japan, 104-0061

Hachioji, Tokyo, Japan, 192-0046

Setagaya-ku, Tokyo, Japan, 157-0066

Setagaya-ku, Tokyo, Japan, 156-0042

Toshima-ku, Tokyo, Japan, 171-0021

Kyoto, Japan, 612-0064

Osaka, Japan, 530-0013

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

Click here to find results for studies related to Bayer Healthcare products. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier:	NCT00511797 History of Changes
Other Study ID Numbers:	91615, 310283
Study First Received:	August 3, 2007
Results First Received:	April 15, 2010
Last Updated:	December 26, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:

Dysmenorrhea
Dysmenorrheal score
Drospirenone
DRSP
Ethinylestradiol

Additional relevant MeSH terms:

Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Ethinyl Estradiol
Drospirenone

Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013