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Study of Safety and Efficacy of an Oral Contraceptive

Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00391807
Enrollment
1683
Registered
2006-10-24
Start date
2006-11-30
Completion date
2008-09-30
Last updated
2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Contraception

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.

Interventions

DRUGNorethindrone acetate/ethinyl estradiol

one tablet per day

Sponsors

Warner Chilcott
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,13 cycles, 28 days each (1 year)
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population13 Cycles, 28 days each (1 year)

Secondary

MeasureTime frameDescription
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population6 cycles, 28 days each (168 days)—
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population13 cycles, 28 days each (1 year)—
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population2 Cycles, 28 days each (56 days)MITT Population
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population6 cycles, 28 days each (168 days)MITT Population
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population13 cycles, 28 days each (1 year)MITT Population
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population2 cycles, 28 days each (56 days)—
Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population6 cycles, 28 days each (168 days)—
Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population6 cycles, 28 days each (168 days)—
Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population12 cycles, 28 days each (336 days)—
Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population2 cycles, 28 days each (56 days)—
Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population6 cycles, 28 days each (168 days)—
Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population13 cycles, 28 days each (1 year)—
Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population2 cycles, 28 days each (56 days)—
Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population2 cycles, 28 days each (56 days)—
Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population13 cycles, 28 days each (1 year)—

Countries

United States

Participant flow

Recruitment details

Recruitment period 01 Nov '06 thru 24 Aug '08

Participants by arm

ArmCount
Norethindrone/Ethinyl Estradiol
1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1,683
Total1,683

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event177
Overall StudyDid not receive study medication23
Overall StudyLost to Follow-up227
Overall StudyPregnancy25
Overall StudyProtocol Violation20
Overall StudyVarious96
Overall StudyWithdrawal by Subject147

Baseline characteristics

CharacteristicNorethindrone/Ethinyl Estradiol
Age Continuous28.6 years
STANDARD_DEVIATION 6.9
Age, Customized
18-35 years
1295 participants
Age, Customized
>35 years
287 participants
Gender
Female
1582 participants
Gender
Male
0 participants
Region of Enrollment
United States
1582 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
390 / 1,660
serious
Total, serious adverse events
15 / 1,660

Outcome results

Primary

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population

Time frame: 13 Cycles, 28 days each (1 year)

Population: MITT Population, All Subjects 18-45 years old, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population2.167 Pregnancy Rate
Primary

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,

Time frame: 13 cycles, 28 days each (1 year)

Population: Modified Intent to Treat Population (MITT), Women Aged 18-35, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,2.554 Pregnancy Rate
Secondary

Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population

Time frame: 12 cycles, 28 days each (336 days)

Population: MITT Population

ArmMeasureValue (MEDIAN)Dispersion
Norethindrone/Ethinyl EstradiolMedian Duration of Withdrawal Bleeding, Cycle 12, MITT Population3.85 DaysStandard Deviation 2.07
Secondary

Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population

Time frame: 2 cycles, 28 days each (56 days)

Population: MITT Population

ArmMeasureValue (MEDIAN)Dispersion
Norethindrone/Ethinyl EstradiolMedian Duration of Withdrawal Bleeding, Cycle 2, MITT Population3.93 DaysStandard Deviation 2.18
Secondary

Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population

Time frame: 6 cycles, 28 days each (168 days)

Population: MITT Population

ArmMeasureValue (MEDIAN)Dispersion
Norethindrone/Ethinyl EstradiolMedian Duration of Withdrawal Bleeding, Cycle 6, MITT Population3.99 DaysStandard Deviation 2.11
Secondary

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population

MITT Population

Time frame: 13 cycles, 28 days each (1 year)

Population: MITT Population

ArmMeasureValue (MEAN)Dispersion
Norethindrone/Ethinyl EstradiolNumber of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population1.81 Bleeding/Spotting DaysStandard Deviation 3.01
Secondary

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population

MITT Population

Time frame: 2 Cycles, 28 days each (56 days)

Population: MITT Population

ArmMeasureValue (MEAN)Dispersion
Norethindrone/Ethinyl EstradiolNumber of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population3.21 Bleeding/Spotting DaysStandard Deviation 4.15
Secondary

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population

MITT Population

Time frame: 6 cycles, 28 days each (168 days)

Population: MITT Population

ArmMeasureValue (MEAN)Dispersion
Norethindrone/Ethinyl EstradiolNumber of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population2.00 Bleeding/Spotting DaysStandard Deviation 3.12
Secondary

Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population

Time frame: 13 cycles, 28 days each (1 year)

Population: MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPercentage of Subjects With Amenorrhea, Cycle 13, MITT Population49.1 Percentage of Participants
Secondary

Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population

Time frame: 2 cycles, 28 days each (56 days)

Population: MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPercentage of Subjects With Amenorrhea, Cycle 2, MITT Population30.7 Percentage of Participants
Secondary

Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population

Time frame: 6 cycles, 28 days each (168 days)

Population: MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPercentage of Subjects With Amenorrhea, Cycle 6, MITT Population42.9 Percentage of Participants
Secondary

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population

Time frame: 13 cycles, 28 days each (1 year)

Population: MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPercentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population22.4 Percentage of Participants
Secondary

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population

Time frame: 2 cycles, 28 days each (56 days)

Population: MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPercentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population34.8 Percentage of Participants
Secondary

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population

Time frame: 6 cycles, 28 days each (168 days)

Population: MITT Population

ArmMeasureValue (NUMBER)
Norethindrone/Ethinyl EstradiolPercentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population25.0 Percentage of Participants
Secondary

Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population

Time frame: 13 cycles, 28 days each (1 year)

Population: MITT Population

ArmMeasureValue (MEAN)Dispersion
Norethindrone/Ethinyl EstradiolTotal Number of Bleeding Days Per Cycle, Cycle 13, MITT Population3.36 DaysStandard Deviation 4.51
Secondary

Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population

Time frame: 2 cycles, 28 days each (56 days)

Population: MITT Population

ArmMeasureValue (MEAN)Dispersion
Norethindrone/Ethinyl EstradiolTotal Number of Bleeding Days Per Cycle, Cycle 2, MITT Population4.57 DaysStandard Deviation 4.94
Secondary

Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population

Time frame: 6 cycles, 28 days each (168 days)

Population: MITT Population

ArmMeasureValue (MEAN)Dispersion
Norethindrone/Ethinyl EstradiolTotal Number of Bleeding Days Per Cycle, Cycle 6, MITT Population3.00 DaysStandard Deviation 3.73

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026