Study of Bleeding With Extended Administration of an Oral Contraceptive

Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338052

Enrollment

207

Registered

2006-06-20

Start date

2006-06-30

Completion date

2007-05-31

Last updated

2008-05-08

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 an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.

Interventions

DRUGNorethindrone 1 mg / ethinyl estradiol 20 mcg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women * Age 25-40 * History of regular cycles

Exclusion criteria

* Current or recent (within 2 months) users of hormonal contraceptives * Contraindications for use of hormonal contraception * Conditions which affect the absorption or metabolism of steroid hormones * BMI \> 35

Design outcomes

Primary

Measure	Time frame
Number of bleeding/spotting days/episodes per treatment cycle	—

Secondary

Measure	Time frame
Satisfaction	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026