Effect on Primary Dysmenorrhea - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00909857

Purpose

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Condition	Intervention	Phase
Primary Dysmenorrhea	Drug: Qlaira (EV/DNG, BAY86-5027); SH T00658ID Drug: Ethinylestradiol + Levonorgestrel	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea

Resource links provided by NLM:

Drug Information available for: Ethinyl estradiol Levonorgestrel

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary objective of this study is to show superiority of SH T00658ID over Miranova with respect to the number of days with dysmenorrheic pain in a defined period, i.e. comparison between two baseline cycles and two treatment cycles. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Score points of dysmenorrheic pain in a defined period, i.e. comparison between 2 baseline cycles and 2 treatment cycles [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of days with pelvic pain independent of occurrence of vaginal bleeding (2 baseline vs. 2 treatment cycles) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of days with dysmenorrheic pain during unscheduled bleedings (2 baseline vs. 2 treatment cycles) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	507
Study Start Date:	April 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Qlaira (EV/DNG, BAY86-5027); SH T00658ID Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Active Comparator: Arm 2	Drug: Ethinylestradiol + Levonorgestrel Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval

Eligibility

Ages Eligible for Study:	14 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.

Exclusion Criteria:

Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
Obesity: body mass index (BMI) > 32 kg/m2
Hypersensitivity to any of the study drug ingredients
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
Abuse of alcohol, drugs, or medicines (e.g. laxatives)
Other contraceptive methods:
- Sterilization
- Oral, vaginal or transdermal hormonal contraception during treatment
- Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
Major surgery scheduled for the study period

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909857

Show 44 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00909857 History of Changes
Other Study ID Numbers:	91781, EudraCT: 2008-005625-11, 312042
Study First Received:	April 24, 2009
Last Updated:	July 14, 2011
Health Authority:	Canada: Health Canada; Chile : Public Health Institute; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Philippines: Bureau of Food and Drugs; United States: Food and Drug Administration; Venezuela : National Institute of Hygiene Rafael Rangel

Keywords provided by Bayer:

Primary Dysmenorrhea
Oral Contraception

Additional relevant MeSH terms:

Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Ethinyl Estradiol
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on February 09, 2012