Trial Condition(s):

Dysmenorrhea

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

Bayer Identifier:

91615

ClinicalTrials.gov Identifier:

NCT00511797

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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
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Phase
2/3
Could I receive a placebo?
Yes
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Maebashi, Japan, 371-0024

Status
Completed
 
Locations

Investigative Site

Setagaya-ku, Japan, 157-0066

Status
Completed
 
Locations

Investigative Site

Toshima-ku, Japan, 171-0021

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 231-0861

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 530-0013

Status
Completed
 
Locations

Investigative Site

Nishinomiya, Japan, 663-8204

Status
Completed
 
Locations

Investigative Site

Sendai, Japan, 981-0933

Status
Completed
 
Locations

Investigative Site

Setagaya-ku, Japan, 156-0042

Status
Completed
 
Locations

Investigative Site

Chuo-ku, Japan, 104-0061

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0021

Status
Completed
 
Locations

Investigative Site

Hachioji, Japan, 192-0046

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 612-0064

Status
Completed
 

Trial Design