Clinical trial NCT00391807: Study of Safety and Efficacy of an Oral Contraceptive
Official title: Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraception
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2006-10-24
Enrollment: 1683
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.


Eligibility criteria: Inclusion Criteria:

* Healthy Women
* Age 18-45
* At risk for pregnancy
* History of regular cycles

Exclusion Criteria:

* Contraindications for use of hormonal contraception
* Conditions which affect the absorption or metabolism of steroid hormones
* BMI \> 35

Primary outcomes:
measure: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,
timeFrame: 13 cycles, 28 days each (1 year)
measure: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population
timeFrame: 13 Cycles, 28 days each (1 year)
Secondary outcomes:
measure: Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population
timeFrame: 2 Cycles, 28 days each (56 days)
measure: Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population
timeFrame: 6 cycles, 28 days each (168 days)
measure: Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population
timeFrame: 13 cycles, 28 days each (1 year)
measure: Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population
timeFrame: 2 cycles, 28 days each (56 days)
measure: Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population
timeFrame: 6 cycles, 28 days each (168 days)
measure: Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population
timeFrame: 13 cycles, 28 days each (1 year)
measure: Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population
timeFrame: 2 cycles, 28 days each (56 days)
measure: Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population
timeFrame: 6 cycles, 28 days each (168 days)
measure: Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population
timeFrame: 12 cycles, 28 days each (336 days)
measure: Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population
timeFrame: 2 cycles, 28 days each (56 days)
measure: Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population
timeFrame: 6 cycles, 28 days each (168 days)
measure: Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population
timeFrame: 13 cycles, 28 days each (1 year)
measure: Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population
timeFrame: 2 cycles, 28 days each (56 days)
measure: Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population
timeFrame: 6 cycles, 28 days each (168 days)
measure: Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population
timeFrame: 13 cycles, 28 days each (1 year)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Denver
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Boynton Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Longwood
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Plantation
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Roswell
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Champaign
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Warner Chilcott Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Berlin
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Moorestown
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Warner Chilcott Investigational Site
state: New Mexico
city: Cary
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Warner Chilcott Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Warner Chilcott Investigational Site
state: Oregon
city: Portland
country: United States
facility: Warner Chilcott Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Pottstown
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Houston
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Magna
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Sandy
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Sponsor GmbH
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References:
citation: Nakajima ST, Pappadakis J, Archer DF. Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive. Contraception. 2016 Jan;93(1):52-7. doi: 10.1016/j.contraception.2015.09.013. Epub 2015 Sep 26.
citation: Archer DF, Nakajima ST, Sawyer AT, Wentworth J, Trupin S, Koltun WD, Gilbert RD, Ellman H. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive. Obstet Gynecol. 2013 Sep;122(3):601-7. doi: 10.1097/AOG.0b013e3182a1741c.