check_circleStudy 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
  • - 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
  • - 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
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Baseline and up to 4 Cycles (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change from baseline in total dysmenorrheal score at Cycle 1 up to Cycle 4
    date_rangeTime Frame:
    Baseline and up to 4 Cycles (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with severity of lower abdominal pain during menstruation at Cycle 4
    date_rangeTime Frame:
    Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with severity of low back pain during menstruation at Cycle 4
    date_rangeTime Frame:
    Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with severity of headache during menstruation at Cycle 4
    date_rangeTime Frame:
    Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with severity of nausea or vomiting during menstruation at Cycle 4
    date_rangeTime Frame:
    Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with total pelvic pain score at times other than during menstruation at Cycle 4
    date_rangeTime Frame:
    Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation at Cycle 4
    date_rangeTime Frame:
    From baseline up to Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation at Cycle 4
    date_rangeTime Frame:
    Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in endometrial thickness after 4-cycle treatment
    date_rangeTime Frame:
    From baseline to Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes
    date_rangeTime Frame:
    For the first 90 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting days
    date_rangeTime Frame:
    For the first 90 days
    enhanced_encryption
    Safety Issue:
    No
  • Participants with withdrawal bleeding
    date_rangeTime Frame:
    At Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Participants with intracyclic bleeding
    date_rangeTime Frame:
    At Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Participants with non-heavy intracyclic bleeding
    date_rangeTime Frame:
    At Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Participants with non-heavy withdrawal bleeding
    date_rangeTime Frame:
    At Cycle 4 (28 dyas per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in serum carbohydrate antigen-125 (CA125) after 4-cycle treatment
    date_rangeTime Frame:
    From baseline to Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in serum C-reactive protein (CRP) after 4-cycle treatment
    date_rangeTime Frame:
    From baseline to Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in serum estradiol level after 4-cycle treatment
    date_rangeTime Frame:
    From baseline to Cycle 4 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in serum progesterone level at Cycle 4
    date_rangeTime Frame:
    From baseline to Cycle 4 (28 days per cycle)
    enhanced_encryption
    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
4

Additional Information

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