NCT00511797

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 4, 2010

Completed
Last Updated

January 26, 2017

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

August 3, 2007

Results QC Date

April 15, 2010

Last Update Submit

November 30, 2016

Conditions

Dysmenorrhea

Keywords

DysmenorrheaDysmenorrheal scoreDrospirenoneDRSPEthinylestradiol

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (19)

  • Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4

    Baseline and up to 4 Cycles (28 days per cycle)

  • Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4

    Cycle 4 (28 days per cycle)

  • Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4

    Cycle 4 (28 days per cycle)

  • Number of Participants With Severity of Headache During Menstruation at Cycle 4

    Cycle 4 (28 days per cycle)

  • Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4

    Cycle 4 (28 days per cycle)

  • +14 more secondary outcomes

Study Arms (4)

DRSP 1 mg/EE 20 μg

EXPERIMENTAL

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

Drug: SH T04740B

DRSP 2 mg/EE 20 μg

EXPERIMENTAL

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

Drug: SH T04740F

DRSP 3 mg/EE 20 μg

EXPERIMENTAL

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

Drug: SH T00186DF

Placebo

PLACEBO COMPARATOR

1 tablet per day placebo for 28 days in each 28-day cycle

Drug: Placebo

Interventions

SH T04740BDRUG

Drospirenone 1mg/EE 20µg (ß-CDC)

DRSP 1 mg/EE 20 μg
SH T00186DFDRUG

Drospirenone 3 mg/EE 20µg (ß-CDC)

DRSP 3 mg/EE 20 μg
SH T04740FDRUG

Drospirenone 2 mg/EE 20µg (ß-CDC)

DRSP 2 mg/EE 20 μg
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Maebashi, Gunma, 371-0024, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0021, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, 663-8204, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 231-0861, Japan

Location

Unknown Facility

Kyoto, Kyoto, 612-0064, Japan

Location

Unknown Facility

Sendai, Miyagi, 981-0933, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0013, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0061, Japan

Location

Unknown Facility

Hachiōji, Tokyo, 192-0046, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 156-0042, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 157-0066, Japan

Location

Unknown Facility

Toshima-ku, Tokyo, 171-0021, Japan

Location

Related Publications (2)

  • 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)

    RESULT

  • Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.

    PMID: 37523477DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Therapeutic Area Head
Organization
BAYER
clinical-trials-contact@bayerhealthcare.com

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 6, 2007

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 26, 2017

Results First Posted

October 4, 2010

Record last verified: 2016-11

Locations

JP(12)