Study Completed

Dysmenorrhea

Bayer Identifier:

91615

ClinicalTrials.gov Identifier:

NCT00511797

EudraCT Number:

Not Available

EU CT Number:

Not Available

SH T00186 Phase II/ III optimal Drospirenone (DRSP) dose finding and placebo-controlled comparative study

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

20 - N/A

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)

Trial summary

Enrollment Goal

249

Trial Dates

July 2007 - January 2009

Phase

Phase 2/Phase 3

Could I Receive a placebo

Yes

Products

YAZ (EE20/DRSP, BAY86-5300)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Maebashi, 371-0024, Japan
Completed		Setagaya-ku, 157-0066, Japan
Completed		Toshima-ku, 171-0021, Japan
Completed		Yokohama, 231-0861, Japan
Completed		Osaka, 530-0013, Japan
Completed		Nishinomiya, 663-8204, Japan
Completed		Sendai, 981-0933, Japan
Completed		Setagaya-ku, 156-0042, Japan
Completed		Chuo-ku, 104-0061, Japan
Completed		Kobe, 650-0021, Japan
Completed		Hachioji, 192-0046, Japan
Completed		Kyoto, 612-0064, Japan

Primary Outcome

Change from baseline in total dysmenorrheal score at final evaluation
Time Frame:
Baseline and up to 4 Cycles (28 days per cycle)
Safety Issue:
No

Secondary Outcome

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)
Safety Issue:
No
Number of participants with severity of lower abdominal pain during menstruation at Cycle 4
Time Frame:
Cycle 4 (28 days per cycle)
Safety Issue:
No
Number of participants with severity of low back pain during menstruation at Cycle 4
Time Frame:
Cycle 4 (28 days per cycle)
Safety Issue:
No
Number of participants with severity of headache during menstruation at Cycle 4
Time Frame:
Cycle 4 (28 days per cycle)
Safety Issue:
No
Number of participants with severity of nausea or vomiting during menstruation at Cycle 4
Time Frame:
Cycle 4 (28 days per cycle)
Safety Issue:
No
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)
Safety Issue:
No
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)
Safety Issue:
No
Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation at Cycle 4
Time Frame:
Cycle 4 (28 days per cycle)
Safety Issue:
No
Change from baseline in endometrial thickness after 4-cycle treatment
Time Frame:
From baseline to Cycle 4 (28 days per cycle)
Safety Issue:
No
Number of bleeding / spotting episodes
Time Frame:
For the first 90 days
Safety Issue:
No
Number of bleeding / spotting days
Time Frame:
For the first 90 days
Safety Issue:
No
Participants with withdrawal bleeding
Time Frame:
At Cycle 4 (28 days per cycle)
Safety Issue:
No
Participants with intracyclic bleeding
Time Frame:
At Cycle 4 (28 days per cycle)
Safety Issue:
No
Participants with non-heavy intracyclic bleeding
Time Frame:
At Cycle 4 (28 days per cycle)
Safety Issue:
No
Participants with non-heavy withdrawal bleeding
Time Frame:
At Cycle 4 (28 dyas per cycle)
Safety Issue:
No
Change from baseline in serum carbohydrate antigen-125 (CA125) after 4-cycle treatment
Time Frame:
From baseline to Cycle 4 (28 days per cycle)
Safety Issue:
No
Change from baseline in serum C-reactive protein (CRP) after 4-cycle treatment
Time Frame:
From baseline to Cycle 4 (28 days per cycle)
Safety Issue:
No
Change from baseline in serum estradiol level after 4-cycle treatment
Time Frame:
From baseline to Cycle 4 (28 days per cycle)
Safety Issue:
No
Change from baseline in serum progesterone level at Cycle 4
Time Frame:
From baseline to Cycle 4 (28 days per cycle)
Safety Issue:
No

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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