To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

NCT00754065 | Completed Phase 3 Results

• 1 other identifier: 13108
• Study Type: interventional
• Target: 409
• Locations: 2 countries
• Sites: 59

Brief Summary

The objective of the study is to compare 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 levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate 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.

Conditions

Contraception

Keywords

Oral contraceptive; Estradiol valerate and dienogest; EV/DNG; comparative tolerability

Outcome Measures

Primary Outcomes (1)

• The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6

  Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

  Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Secondary Outcomes (114)

• The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication

  From Baseline to Cycle 6 (28 days per Cycle)

• The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication

  From Baseline to Cycle 13 (28 days per Cycle)

• Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28

  Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

• Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28

  Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)

• Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21

  Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)

Other Outcomes (2)

• Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6

  Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

• The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6

  Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)

Study Arms (2)

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

EXPERIMENTAL

Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)

Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Ortho Tri-Cyclen Lo

ACTIVE COMPARATOR

Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)

Drug: Ortho Tri Cyclen Lo

Interventions

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) DRUG

Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Ortho Tri Cyclen Lo DRUG

Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo

Ortho Tri-Cyclen Lo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated informed consent
• Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1
• Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of \>/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction)
• 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) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS.
• Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator

You may not qualify if:

• 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
• Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules
• 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
• Undiagnosed abnormal genital bleeding
• Abuse of alcohol, drugs, or medicines (eg, laxatives)
• Other contraceptive methods
• Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
• Simultaneous 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
• Subject is a dependent person, eg: a family member or member of the Investigator's staff
• Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site

Sponsors & Collaborators

• Bayer: lead

Study Sites (59)

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Independence, Arizona, 94925, United States

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Phoenix, Arizona, 85032, United States

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Encinitas, California, 92024, United States

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San Diego, California, 92108, United States

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Santa Monica, California, 90404, United States

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Denver, Colorado, 80206, United States

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Denver, Colorado, 80218, United States

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Littleton, Colorado, 80127, United States

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Clearwater, Florida, 33759, United States

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Jacksonville, Florida, 32207, United States

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West Palm Beach, Florida, 33409, United States

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Decatur, Georgia, 30034, United States

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Boise, Idaho, 83702, United States

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Boise, Idaho, 83712, United States

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Idaho Falls, Idaho, 83406, United States

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Fishers, Indiana, 46037, United States

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Indianapolis, Indiana, 46217, United States

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South Bend, Indiana, 46601, United States

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Metairie, Louisiana, 70006, United States

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Chesterfield, Missouri, 63017, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89128, United States

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New Brunswick, New Jersey, 08901, United States

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Winston-Salem, North Carolina, 94925, United States

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Cincinnati, Ohio, 45246, United States

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Columbus, Ohio, 43213, United States

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Portland, Oregon, 97239-3011, United States

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Philadelphia, Pennsylvania, 19114, United States

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Bristol, Tennessee, 37620, United States

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Memphis, Tennessee, 38120, United States

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Houston, Texas, 77054, United States

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Spokane, Washington, 99207, United States

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La Crosse, Wisconsin, 54601, United States

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Langley, British Columbia, V3A 4H9, Canada

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Bathurst, New Brunswick, E2A 4Z9, Canada

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St. John's, Newfoundland and Labrador, A1A 3R5, Canada

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Halifax, Nova Scotia, B3K 5R3, Canada

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Corunna, Ontario, N0N 1G0, Canada

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Downsview, Ontario, M3J 1N2, Canada

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Hamilton, Ontario, L8L 5G8, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Ottawa, Ontario, K1H 7W9, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Woodstock, Ontario, N4S 5P5, Canada

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Charlottetown, Prince Edward Island, C1A 5Y9, Canada

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Drummondville, Quebec, J2B 7T1, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Shawinigan, Quebec, G9N 2H6, Canada

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Ste-Foy, Quebec, G1V 4X7, Canada

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Regina, Saskatchewan, S4P 3X1, Canada

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Saskatoon, Saskatchewan, S7H 5M3, Canada

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Saskatoon, Saskatchewan, S7K 7H9, Canada

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Québec, G3K 2P8, Canada

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Related Publications (1)

• Jensen JT, Parke S, Mellinger U, Serrani M, Mabey RG Jr. Hormone withdrawal-associated symptoms: comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate. Eur J Contracept Reprod Health Care. 2013 Aug;18(4):274-83. doi: 10.3109/13625187.2013.785516. Epub 2013 May 2.

  PMID: 23638631 RESULT

MeSH Terms

Interventions

Estradiol; dienogest; Moxifloxacin

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 17, 2008
• Study Start: September 8, 2008
• Primary Completion: May 10, 2011
• Study Completion: May 10, 2011
• Last Updated: November 20, 2024
• Results First Posted: August 28, 2012

Record last verified: 2024-10

Locations

US (34); CA (25)