Effect on Primary Dysmenorrhea
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
3 other identifiers
interventional
507
6 countries
41
Brief Summary
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2009
41 active sites
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
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 24, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
February 27, 2012
CompletedAugust 24, 2015
August 1, 2015
1.6 years
April 24, 2009
November 15, 2011
August 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Secondary Outcomes (67)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
- +62 more secondary outcomes
Study Arms (2)
Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
EXPERIMENTALDaily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Ethinyl estradiol, Levonorgestrel (Miranova)
ACTIVE COMPARATORDaily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Interventions
Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (41)
Unknown Facility
Tucson, Arizona, 85741, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Leesburg, Florida, 34748, United States
Unknown Facility
Sandy Springs, Georgia, 30328, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15206, United States
Unknown Facility
La Crosse, Wisconsin, 54691, United States
Unknown Facility
Langley, British Columbia, V3A 4H9, Canada
Unknown Facility
Toronto, Ontario, M5C 2T2, Canada
Unknown Facility
Pointe-Claire, Quebec, H9R 4S3, Canada
Unknown Facility
Ste-Foy, Quebec, G1V 4X7, Canada
Unknown Facility
Regina, Saskatchewan, S4P 3X1, Canada
Unknown Facility
Santiago, Chile
Unknown Facility
Talcahuano, Chile
Unknown Facility
Temuco, 4790711, Chile
Unknown Facility
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Unknown Facility
Hamburg, Hamburg, 22159, Germany
Unknown Facility
Cologne, North Rhine-Westphalia, 50931, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45127, Germany
Unknown Facility
Leipzig, Saxony, 04207, Germany
Unknown Facility
Bernburg, Saxony-Anhalt, 06406, Germany
Unknown Facility
Magdeburg, Saxony-Anhalt, 39126, Germany
Unknown Facility
Francavilla Fontana, Brindisi, 72021, Italy
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Brescia, 25123, Italy
Unknown Facility
Milan, 20121, Italy
Unknown Facility
Modena, 41124, Italy
Unknown Facility
Perugia, 06156, Italy
Unknown Facility
Roma, 00161, Italy
Unknown Facility
Siena, 53100, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Udine, 33100, Italy
Unknown Facility
Cebu, Philippines
Unknown Facility
Cebu City, Philippines
Unknown Facility
Davao City, Philippines
Unknown Facility
Metro Manila, 1000, Philippines
Unknown Facility
Metro Manila, Philippines
Unknown Facility
Quezon City, Philippines
Related Publications (2)
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: 37523477DERIVEDPetraglia F, Parke S, Serrani M, Mellinger U, Romer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int J Gynaecol Obstet. 2014 Jun;125(3):270-4. doi: 10.1016/j.ijgo.2013.11.017. Epub 2014 Mar 11.
PMID: 24713413DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2009
First Posted
May 29, 2009
Study Start
April 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
August 24, 2015
Results First Posted
February 27, 2012
Record last verified: 2015-08