Brief Summary

This is a 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 of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

938

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jan 2004

Shorter than P25 for phase_3

Geographic Reach

1 country

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

January 1, 2004

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed

4.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

March 22, 2011

Completed

Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

10 months

First QC Date

June 30, 2009

Results QC Date

February 22, 2011

Last Update Submit

April 15, 2013

Conditions

Prevention of Pregnancy

Keywords

Contraception

Outcome Measures

Primary Outcomes (1)

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population
Pearl Index = 1300 \* number of pregnancies/number of women-cycles of treatment
5.6 months (6 - 28 day cycles)

Secondary Outcomes (1)

Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
5.6 months (6 - 28 day cycles)

Study Arms (2)

24 Day NA/EE

EXPERIMENTAL

Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle

Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days

21 Day NA/EE

ACTIVE COMPARATOR

Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days

Interventions

Norethindrone Acetate/Ethinyl Estradiol 24 DaysDRUG

One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets

24 Day NA/EE

Norethindrone Acetate /Ethinyl Estradiol 21 DaysDRUG

One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Also known as: 21 Day NA/EE

21 Day NA/EE

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.