Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00461305

Purpose

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Condition	Intervention	Phase
Dysmenorrhea	Drug: Ethinylestradiol / Drospirenon ( SH TO4740B Drug: Ethinylestradiol / Drospirenon ( SH TO4740F) Drug: Ethinylestradiol / Drospirenon ( SH TOO186DF) Drug: Ethinylestradiol / Drospirenon	Phase III

MedlinePlus related topics: Menstruation Nausea and Vomiting Pelvic Pain

Drug Information available for: Ethinyl estradiol 1,2-Dihydrospirorenone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Single-Blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 mg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)

Further study details as provided by Bayer:

Primary Outcome Measures:

Change in total dysmenorrheal score at the final evaluation from baseline [ Time Frame: 5 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the total dysmenorrheal score [ Time Frame: 5 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]
Changes over time in total dysmenorrheal score [ Time Frame: 5 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]
Change in severity of lower abdominal pain, lumbago, headache, and nausea or vomiting during menstruation [ Time Frame: 5 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]
Change of pelvic pain score at pelvic pain score at times other than during menstruation periods [ Time Frame: 5 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]
Change of VAS for dysmenorrhea and pelvic pain at pelvic pain score at times other than during menstruation periods [ Time Frame: 4 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]
Status of vaginal bleeding [ Time Frame: 4 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]
Time Frame for all secondary outcomes: SH T00186DF Group: 13 cycles; SH T04740D Group: 6 cycles [ Time Frame: 4 cycles (28 days per 1 cycle) ] [ Designated as safety issue: No ]

Estimated Enrollment:	390
Study Start Date:	February 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 3: Experimental	Drug: Ethinylestradiol / Drospirenon ( SH TOO186DF) DRSP 3 mg/EE 20 µg (ß-CDC)] (24 tablets)+ [placebo] (4 tablets)}are to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles).
Arm 4: Placebo Comparator	Drug: Ethinylestradiol / Drospirenon [placebo] (24 tablets) + [placebo] (4 tablets) is to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles).
Arm 1: Experimental	Drug: Ethinylestradiol / Drospirenon ( SH TO4740B DRSP 1 mg/EE 20 µg (ß-CDC)] (24 tablets)+ [placebo] (4 tablets) are to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles).
Arm 2: Experimental	Drug: Ethinylestradiol / Drospirenon ( SH TO4740F) [DRSP 2 mg/EE 20 µg (ß-CDC)] (24 tablets)+ [placebo] (4 tablets)} are to be taken orally in the form of a single tablet once daily (the tablet is to be taken at a fixed time, but whether taken before or after a meal is unimportant) for 16 weeks (4 cycles)

Detailed Description:

The SH T00186DF group is to be treated by oral administration for 52 weeks, 13 cycles. The SH T04740D group is to be treated by oral administration for 24 weeks, 6 cycles

The trial is sponsored by Bayer Schering Pharma AG, Germany.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 20 years or older at obtaining informed consent
Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Exclusion Criteria:

Patients with ovarian chocolate cysts
Patients with fibroid needed to be treated
Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
Patients with undiagnosed abnormal vaginal bleeding
Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease 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 prodromata
Patients with pulmonary hypertension or valvular heart disease
Patients who are regularly taking nutritional products that contain St. John's Wort
Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461305

Locations

Japan

Osaka, Japan, 530-0013

Osaka, Japan, 534-0014
Japan, Aichi

Nagoya, Aichi, Japan, 460-0011

Nagoya, Aichi, Japan, 460-0007

Nagoya, Aichi, Japan, 464-0066
Japan, Gunma

Maebashi, Gunma, Japan, 371-0024

Takasaki, Gunma, Japan, 370-0883
Japan, Hyogo

Kobe, Hyogo, Japan, 650-0021

Nishinomiya, Hyogo, Japan, 663-8204
Japan, Kanagawa

Yokohama, Kanagawa, Japan, 231-0861

Yamato, Kanagawa, Japan, 242-0007
Japan, Miyagi

Sendai, Miyagi, Japan, 981-0933

Sendai, Miyagi, Japan, 980-0021

Sendai, Miyagi, Japan, 984-0042
Japan, Osaka

Toyonaka, Osaka, Japan, 560-0022
Japan, Tokyo

Suginami-ku, Tokyo, Japan, 167-0051

Shinagawa-ku, Tokyo, Japan, 140-0013

Ota-ku, Tokyo, Japan, 144-0052

Setagaya-ku, Tokyo, Japan, 157-0066

Setagaya-ku, Tokyo, Japan, 156-0042

Machida, Tokyo, Japan, 194-0022

Shibuya-ku, Tokyo, Japan, 150-0013

Toshima-ku, Tokyo, Japan, 171-0021

Musashino, Tokyo, Japan, 180-0003

Hachioji, Tokyo, Japan, 192-0046

Chuo-ku, Tokyo, Japan, 104-0061

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91616, 310284
Study First Received:	April 17, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00461305
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:

Dysmenorrhea
Intracyclic bleeding
Drospirenone (DRSP)
Ethinylestradiol

Study placed in the following topic categories:

Estradiol valerate
Ethinyl Estradiol
Pain
Estradiol 17 beta-cypionate
Hemorrhage
Estradiol
Signs and Symptoms

Pelvic Pain
Dysmenorrhea
Menstruation Disturbances
Estradiol 3-benzoate
Drospirenone
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Pathologic Processes
Aldosterone Antagonists
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 10, 2009