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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00511797
Other study ID # 91615
Secondary ID 310283
Status Completed
Phase Phase 2/Phase 3
First received August 3, 2007
Last updated December 25, 2013
Start date July 2007
Est. completion date January 2009

Study information

Verified date December 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 249
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SH T04740B
Drospirenone 1mg/EE 20µg (ß-CDC)
SH T00186DF
Drospirenone 3 mg/EE 20µg (ß-CDC)
SH T04740F
Drospirenone 2 mg/EE 20µg (ß-CDC)
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Momoeda M, et al. Treatment of Functional and Organic Dysmenorrhea - Investigation of the Efficacy and Safety of Drospirenone/Ethinylestradiol Combination Tablet (YAZ). Sanka to Fujinka (Obstetrics and Gynecology), 2010: 77 (8) 977-88 (in Japanese)

Outcome

Type Measure Description Time frame Safety issue
Primary 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.) Baseline and up to 4 Cycles (28 days per cycle) No
Secondary Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4 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. Baseline and up to 4 Cycles (28 days per cycle) No
Secondary 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). Cycle 4 (28 days per cycle) No
Secondary 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). Cycle 4 (28 days per cycle) No
Secondary 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). Cycle 4 (28 days per cycle) No
Secondary 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). Cycle 4 (28 days per cycle) No
Secondary 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. Cycle 4 (28 days per cycle) No
Secondary 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). From baseline up to Cycle 4 (28 days per cycle) No
Secondary 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). Cycle 4 (28 days per cycle) No
Secondary 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. From baseline to Cycle 4 (28 days per cycle) No
Secondary 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. For the first 90 days No
Secondary Number of Bleeding / Spotting Days 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. For the first 90 days No
Secondary Participants With Withdrawal Bleeding Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. At Cycle 4 (28 days per cycle) No
Secondary Participants With Intracyclic Bleeding Intracyclic bleedings were defined as bleedings while a participant takes active drugs. At Cycle 4 (28 days per cycle) No
Secondary Participants With Non-heavy Intracyclic Bleeding Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). At Cycle 4 (28 days per cycle) No
Secondary Participants With Non-heavy Withdrawal Bleeding Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). At Cycle 4 (28 dyas per cycle) No
Secondary 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. From baseline to Cycle 4 (28 days per cycle) No
Secondary 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. From baseline to Cycle 4 (28 days per cycle) No
Secondary Change From Baseline in Serum Estradiol Level After 4-cycle Treatment Estradiol is a predominant sex hormone that presents in female. From baseline to Cycle 4 (28 days per cycle) No
Secondary Change From Baseline in Serum Progesterone Level at Cycle 4 Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc. From baseline to Cycle 4 (28 days per cycle) No
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