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History of Changes for Study: NCT00754065
To Compare SH T00658ID to Ortho Tri-Cyclen Lo (US/Canada)
Latest version (submitted July 15, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 16, 2008 None (earliest Version on record)
2 October 14, 2008 Contacts/Locations, Study Status, Eligibility, Conditions, Sponsor/Collaborators and Study Identification
3 October 15, 2008 Contacts/Locations, Conditions, Eligibility and Study Status
4 October 21, 2008 Contacts/Locations, Arms and Interventions, Eligibility and Study Status
5 November 12, 2008 Contacts/Locations, Study Status and Oversight
6 December 3, 2008 Contacts/Locations, Study Status, Eligibility and Oversight
7 January 5, 2009 Study Status, Contacts/Locations and Eligibility
8 February 5, 2009 Contacts/Locations and Study Status
9 March 5, 2009 Contacts/Locations, Study Status, Eligibility and Oversight
10 March 9, 2009 Eligibility, Study Description and Study Status
11 March 11, 2009 Outcome Measures, Contacts/Locations and Study Status
12 April 2, 2009 Contacts/Locations, Study Status and Oversight
13 May 4, 2009 Contacts/Locations and Study Status
14 June 2, 2009 Contacts/Locations and Study Status
15 July 1, 2009 Contacts/Locations and Study Status
16 October 9, 2009 Contacts/Locations, Study Status, Study Identification and Conditions
17 November 23, 2009 Study Status, Outcome Measures, Conditions, Eligibility, Study Design and Study Description
18 January 8, 2010 Contacts/Locations and Study Status
19 February 2, 2010 Study Status and Eligibility
20 March 12, 2010 Recruitment Status, Study Status and Contacts/Locations
21 June 24, 2010 Contacts/Locations, Study Design, Study Status and Eligibility
22 September 21, 2010 Study Status
23 December 16, 2010 Study Status
24 January 6, 2011 Study Status
25 February 2, 2011 Study Status
26 May 3, 2011 Study Status, Contacts/Locations and Study Design
27 May 20, 2011 Recruitment Status and Study Status
28 July 6, 2011 Study Status and Contacts/Locations
29 July 25, 2012 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Study Description, Results and Eligibility
30 July 15, 2013 Study Status and References
Comparison Format:

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Study NCT00754065
Submitted Date:  October 14, 2008 (v2)

Open or close this module Study Identification
Unique Protocol ID: 13108
Brief Title: To Compare SH T00658ID to Ortho Tri-Cyclen Lo (US/Canada)
Official Title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, 2-Arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-Associated Symptoms After 6 Cycles of Treatment.
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2008
Overall Status: Recruiting
Study Start: September 2008
Primary Completion: December 2009 [Anticipated]
Study Completion: August 2010 [Anticipated]
First Submitted: September 16, 2008
First Submitted that
Met QC Criteria:
September 16, 2008
First Posted: September 17, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 14, 2008
Last Update Posted: October 15, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bayer
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The objective of the study is to evaluate the superiority of the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a LNG containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.
Detailed Description:
Open or close this module Conditions
Conditions: SH T00658ID
Ortho Tri Cyclen Lo
Keywords: Oral contraceptive,
Estradiol valerate and dienogest (EV/DNG) ,
Comparative tolerability
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 1540 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1 Drug: SH T00658ID
EV/DNG
Active Comparator: Arm 2 Drug: Ortho Tri Cyclen Lo
Ortho Tri Cyclen Lo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The change of pelvic pain (stratum 1) or the change of headache (stratum 2) as determined by the change of average VAS (Visual Analog Scale) during cycle days 22 to 28
[ Time Frame: From Baseline to Cycle 6. ]

Secondary Outcome Measures:
1. Change in VAS
[ Time Frame: From Baseline to Cycle 3 ]

2. Rescue medication consumption
[ Time Frame: Baseline to Cycle 6 and Baseline to Cycle 13 ]

3. Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting)
[ Time Frame: During cycle days 22 to 28, Baseline to Cycle 6 and Baseline to Cycle 13 ]

4. Prevalence of individual hormone-related symptoms
[ Time Frame: During cycle days 1 to 21, Baseline to Cycle 6 and Baseline to Cycle 13 ]

5. Prevalence of individual hormone-related symptoms during hormone-free interval
[ Time Frame: Cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator Ortho Tri Cyclen Lo capsules ]

6. Change in VAS of the hormone withdrawal-associated symptoms pelvic pain or headache
[ Time Frame: During cycle days 22 to 28 from Baseline to Cycle 13 ]

7. Bleeding pattern and cycle control
[ Time Frame: Baseline to Cycle 13 ]

8. QoL Questionnaires
[ Time Frame: Baseline to Cycle 13 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Signed and dated informed consent
  • Age between 18 and 50 years (inclusive), smokers maximum age of 30 years (inclusive) at Visit 1
  • Otherwise healthy female subjects requesting contraception and currently using a LNG containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of ≥ 35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction [Section 11.3]
  • Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening)
  • Able to tolerate Ibuprofen and willing to use only Ibuprofen supplied by the Sponsor

Exclusion Criteria:

  • Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment)
  • Body mass index (BMI) >32 kg/m2
  • Hypersensitivity to any of the study drug ingredients
  • Vegetarians and individuals not consuming pork products
  • Safety relevant laboratory values, provided by the central laboratory, outside inclusion range before start of treatment
  • Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any disease or condition that may worsen under hormonal treatment
Open or close this module Contacts/Locations
Central Contact Person: Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayerhealthcare.com
Central Contact Backup: For trial location information (Phone Menu Options "3" or "4")
Telephone: (+)1-888-84 22937
Study Officials: Bayer Study Director
Study Director
Bayer
Locations: United States, Alabama
[Not yet recruiting]
Montgomery, Alabama, United States, 36116
United States, Arizona
[Not yet recruiting]
Glendale, Arizona, United States, 85304
[Not yet recruiting]
Phoenix, Arizona, United States, 85032
United States, California
[Not yet recruiting]
Encinitas, California, United States, 92024
[Not yet recruiting]
Irvine, California, United States, 92618-3603
[Not yet recruiting]
Pacific Palisades, California, United States, 90272
[Not yet recruiting]
San Diego, California, United States, 92108
[Not yet recruiting]
San Diego, California, United States, 92123
United States, Colorado
[Not yet recruiting]
Denver, Colorado, United States, 80202
[Not yet recruiting]
Littleton, Colorado, United States, 80122
[Not yet recruiting]
Littleton, Colorado, United States, 80127
United States, Florida
[Recruiting]
Clearwater, Florida, United States, 33759
[Not yet recruiting]
Daytona Beach, Florida, United States, 32114
[Not yet recruiting]
Jacksonville, Florida, United States, 32209
[Recruiting]
West Palm Beach, Florida, United States, 33409
United States, Georgia
[Not yet recruiting]
Decatur, Georgia, United States, 30034
United States, Idaho
[Not yet recruiting]
Boise, Idaho, United States, 83702
[Not yet recruiting]
Boise, Idaho, United States, 83712
[Not yet recruiting]
Idaho Falls, Idaho, United States, 83406
United States, Indiana
[Not yet recruiting]
Fishers, Indiana, United States, 46037
[Not yet recruiting]
Indianapolis, Indiana, United States, 46217
[Not yet recruiting]
Indianapolis, Indiana, United States, 46220
[Not yet recruiting]
South Bend, Indiana, United States, 46601
United States, Louisiana
[Not yet recruiting]
Metaire, Louisiana, United States, 70006
United States, Missouri
[Not yet recruiting]
Chesterfield, Missouri, United States, 63017
[Not yet recruiting]
St. Louis, Missouri, United States, 63141
United States, Nebraska
[Not yet recruiting]
Fremont, Nebraska, United States, 68025
[Not yet recruiting]
Lincoln, Nebraska, United States, 68510
United States, Nevada
[Not yet recruiting]
Las Vegas, Nevada, United States, 89128
United States, New Jersey
[Not yet recruiting]
Moorestown, New Jersey, United States, 08057
[Not yet recruiting]
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
[Not yet recruiting]
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
[Not yet recruiting]
Cincinnati, Ohio, United States, 45246
[Not yet recruiting]
Columbus, Ohio, United States, 43213
United States, Oregon
[Not yet recruiting]
Portland, Oregon, United States, 97239
United States, Pennsylvania
[Recruiting]
Philadelphia, Pennsylvania, United States, 19114
[Not yet recruiting]
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
[Not yet recruiting]
Bristol, Tennessee, United States, 37620
[Not yet recruiting]
Memphis, Tennessee, United States, 38120
United States, Texas
[Not yet recruiting]
Houston, Texas, United States, 77054
United States, Wisconsin
[Not yet recruiting]
La Crosse, Wisconsin, United States, 54601
Canada
[Not yet recruiting]
Langley, Canada, V3A 4H9
[Not yet recruiting]
Vancouver, Canada, V6H 2Z6
Canada, Nova Scotia
[Not yet recruiting]
Halifax, Nova Scotia, Canada, B3J 3G9
[Not yet recruiting]
Halifax, Nova Scotia, Canada, B3K 5R3
Canada, Ontario
[Not yet recruiting]
Downsview, Ontario, Canada, M3J 1N2
[Not yet recruiting]
Hamilton, Ontario, Canada, L8M 1K7
[Not yet recruiting]
Newmarket, Ontario, Canada, L3Y 5G8
[Not yet recruiting]
Ottawa, Ontario, Canada, K1H 7W9
[Not yet recruiting]
Ottawa, Ontario, Canada, K2G 4A1
[Not yet recruiting]
Woodstock, Ontario, Canada, N4S 4G3
Canada, Quebec
[Not yet recruiting]
Montreal, Quebec, Canada, H3T 1G7
[Not yet recruiting]
Pointe-Claire, Quebec, Canada, H9R 4S3
[Not yet recruiting]
Shawinigan, Quebec, Canada, G9N 2H6
Canada, Saskatchewan
[Not yet recruiting]
Saskatoon, Saskatchewan, Canada, S7K 7H9
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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