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SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

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ClinicalTrials.gov Identifier: NCT00511797
Recruitment Status : Completed
First Posted : August 6, 2007
Results First Posted : October 4, 2010
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE August 3, 2007
First Posted Date  ICMJE August 6, 2007
Results First Submitted Date  ICMJE April 15, 2010
Results First Posted Date  ICMJE October 4, 2010
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE July 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation [ Time Frame: Baseline and up to 4 Cycles (28 days per cycle) ]
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.)
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2007)
Change in dysmenorrhea score at the final evaluation from baseline [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT00511797 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
  • 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) ]
    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.
  • Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ]
    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).
  • Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ]
    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).
  • Number of Participants With Severity of Headache During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ]
    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).
  • Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ]
    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).
  • 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) ]
    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.
  • 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) ]
    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).
  • Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4 [ Time Frame: Cycle 4 (28 days per cycle) ]
    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).
  • Change From Baseline in Endometrial Thickness After 4-cycle Treatment [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
    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.
  • Number of Bleeding / Spotting Episodes [ Time Frame: For the first 90 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. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.
  • Number of Bleeding / Spotting Days [ Time Frame: For the first 90 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.
  • Participants With Withdrawal Bleeding [ Time Frame: At Cycle 4 (28 days per cycle) ]
    Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
  • Participants With Intracyclic Bleeding [ Time Frame: At Cycle 4 (28 days per cycle) ]
    Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
  • Participants With Non-heavy Intracyclic Bleeding [ Time Frame: At Cycle 4 (28 days per cycle) ]
    Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
  • Participants With Non-heavy Withdrawal Bleeding [ Time Frame: At Cycle 4 (28 dyas per cycle) ]
    Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
  • Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
    CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
  • Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
    CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.
  • Change From Baseline in Serum Estradiol Level After 4-cycle Treatment [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
    Estradiol is a predominant sex hormone that presents in female.
  • Change From Baseline in Serum Progesterone Level at Cycle 4 [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
    Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2007)
  • Changes in dysmenorrhea score over different time points [ Time Frame: 16 weeks ]
  • Change in severity of lower abdominal pain, lumbago, headache, and nausea or vomiting during menstruation [ Time Frame: 16 weeks ]
  • Change of chronic pelvic pain as assessed by a Visual Analog Scale (VAS) [ Time Frame: 16 weeks ]
  • Change in endometrium thickness from baseline [ Time Frame: 16 weeks ]
  • Estradiol serum concentration [ Time Frame: 16 weeks ]
  • Progesteron serum concentration [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
Official Title  ICMJE 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.
Brief Summary The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dysmenorrhea
Intervention  ICMJE
  • Drug: SH T04740B
    Drospirenone 1mg/EE 20µg (ß-CDC)
  • Drug: SH T00186DF
    Drospirenone 3 mg/EE 20µg (ß-CDC)
  • Drug: SH T04740F
    Drospirenone 2 mg/EE 20µg (ß-CDC)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: DRSP 1 mg/EE 20 μg
    1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
    Intervention: Drug: SH T04740B
  • Experimental: DRSP 2 mg/EE 20 μg
    1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
    Intervention: Drug: SH T04740F
  • Experimental: DRSP 3 mg/EE 20 μg
    1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
    Intervention: Drug: SH T00186DF
  • Placebo Comparator: Placebo
    1 tablet per day placebo for 28 days in each 28-day cycle
    Intervention: Drug: Placebo
Publications * 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2010)
249
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2007)
232
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00511797
Other Study ID Numbers  ICMJE 91615
310283 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP