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.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,683

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2006

Geographic Reach

1 country

66 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

October 20, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed

8 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

December 22, 2010

Completed

Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

October 20, 2006

Results QC Date

November 23, 2010

Last Update Submit

April 15, 2013

Conditions

Contraception

Keywords

Contraception

Outcome Measures

Primary Outcomes (2)

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 Population
13 Cycles, 28 days each (1 year)

Secondary Outcomes (15)

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population
2 Cycles, 28 days each (56 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population
6 cycles, 28 days each (168 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population
13 cycles, 28 days each (1 year)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population
2 cycles, 28 days each (56 days)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population
6 cycles, 28 days each (168 days)
+10 more secondary outcomes

Study Arms (1)

study drug

EXPERIMENTAL

Norethindrone/Ethinyl Estradiol

Drug: Norethindrone acetate/ethinyl estradiol

Interventions

Norethindrone acetate/ethinyl estradiolDRUG

one tablet per day

study drug

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.