Trial Condition(s):

Dysmenorrhea

Safety study of Ethinylestradiol/Drospirenone in dysmenorrhea

Bayer Identifier:

91616

ClinicalTrials.gov Identifier:

NCT00461305

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Inclusion Criteria
- Patients aged 20 years or older at obtaining informed consent
- Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
- Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment
Exclusion Criteria
- Patients with ovarian chocolate cysts 
- Patients with fibroid needed to be treated
- Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer 
- Patients with undiagnosed abnormal vaginal bleeding
- Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease 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 prodromata 
- Patients with pulmonary hypertension or valvular heart disease 
- Patients who are regularly taking nutritional products that contain St. John's Wort
- Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
- Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Trial Summary

Enrollment Goal
420
Trial Dates
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Phase
2/3
Could I receive a placebo?
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Koga Clinic

Sendai, Japan, 981-0933

Status
Completed
 
Locations

Kakuta Chieko Clinic

Sendai, Japan, 984-0042

Status
Completed
 
Locations

Yazaki Clinic

Takasaki, Japan, 370-0883

Status
Completed
 
Locations

Takane Clinic

Shinagawa-ku, Japan, 140-0013

Status
Completed
 
Locations

Seijo Kinoshita Hospital

Setagaya-ku, Japan, 157-0066

Status
Completed
 
Locations

Kosugi Clinic

Setagaya-ku, Japan, 156-0042

Status
Completed
 
Locations

Women's Wellness Ginza Clinic

Chuo-ku, Japan, 104-0061

Status
Completed
 
Locations

C:z Ladies Clinic

Shibuya-ku, Japan, 150-0013

Status
Completed
 
Locations

NS Clinic

Hachioji, Japan, 192-0046

Status
Completed
 
Locations

Machida Higashiguchi Clinic

Machida, Japan, 194-0022

Status
Completed
 
Locations

Iida Ladies Clinic

Nagoya, Japan, 460-0007

Status
Completed
 
Locations

Sakie Ladies Clinic

Nagoya, Japan, 464-0066

Status
Completed
 
Locations

Chayamachi Ladies Clinic

Osaka, Japan, 530-0013

Status
Completed
 
Locations

Kawabata Women's Clinic

Osaka, Japan, 534-0014

Status
Completed
 
Locations

Nagaike Clinic

Sendai, Japan, 980-0021

Status
Completed
 
Locations

Iesaka Clinic

Maebashi, Japan, 371-0024

Status
Completed
 
Locations

Suzuran Clinic

Suginami-ku, Japan, 167-0051

Status
Completed
 
Locations

Ito Medical Clinic

Ota-ku, Japan, 144-0052

Status
Completed
 
Locations

Ikebukuro Clinic

Toshima-ku, Japan, 171-0021

Status
Completed
 
Locations

Kichijyouji Lady's Clinic

Musashino, Japan, 180-0003

Status
Completed
 
Locations

Luna Clinic

Yokohama, Japan, 231-0861

Status
Completed
 
Locations

Rinkan Clinic

Yamato, Japan, 242-0007

Status
Completed
 
Locations

Kano's Clinic for Women

Nagoya, Japan, 460-0011

Status
Completed
 
Locations

Yoshimura Ladies Clinic

Toyonaka, Japan, 560-0022

Status
Completed
 
Locations

Hanabusa Clinic

Kobe, Japan, 650-0021

Status
Completed
 
Locations

Kiuchi Ladies Clinic

Nishinomiya, Japan, 663-8204

Status
Completed
 

Trial Design