Clinical trial NCT00511797: SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea
Dysmenorrheal score
Drospirenone
DRSP
Ethinylestradiol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 249
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Total Dysmenorrheal Score at Final Evaluation
timeFrame: Baseline and up to 4 Cycles (28 days per cycle)
Secondary outcomes:
measure: Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
timeFrame: Baseline and up to 4 Cycles (28 days per cycle)
measure: Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
timeFrame: Cycle 4 (28 days per cycle)
measure: Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
timeFrame: Cycle 4 (28 days per cycle)
measure: Number of Participants With Severity of Headache During Menstruation at Cycle 4
timeFrame: Cycle 4 (28 days per cycle)
measure: Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
timeFrame: Cycle 4 (28 days per cycle)
measure: Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
timeFrame: Cycle 4 (28 days per cycle)
measure: Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4
timeFrame: From baseline up to Cycle 4 (28 days per cycle)
measure: Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4
timeFrame: Cycle 4 (28 days per cycle)
measure: Change From Baseline in Endometrial Thickness After 4-cycle Treatment
timeFrame: From baseline to Cycle 4 (28 days per cycle)
measure: Number of Bleeding / Spotting Episodes
timeFrame: For the first 90 days
measure: Number of Bleeding / Spotting Days
timeFrame: For the first 90 days
measure: Participants With Withdrawal Bleeding
timeFrame: At Cycle 4 (28 days per cycle)
measure: Participants With Intracyclic Bleeding
timeFrame: At Cycle 4 (28 days per cycle)
measure: Participants With Non-heavy Intracyclic Bleeding
timeFrame: At Cycle 4 (28 days per cycle)
measure: Participants With Non-heavy Withdrawal Bleeding
timeFrame: At Cycle 4 (28 dyas per cycle)
measure: Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment
timeFrame: From baseline to Cycle 4 (28 days per cycle)
measure: Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment
timeFrame: From baseline to Cycle 4 (28 days per cycle)
measure: Change From Baseline in Serum Estradiol Level After 4-cycle Treatment
timeFrame: From baseline to Cycle 4 (28 days per cycle)
measure: Change From Baseline in Serum Progesterone Level at Cycle 4
timeFrame: From baseline to Cycle 4 (28 days per cycle)
Other outcomes:
Locations:
city: Maebashi
country: Japan
state: Gunma
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Chuo-ku
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Kyoto
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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)