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Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)

NCT00475189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2011-07-25

No results posted yet for this study

Summary

The purpose of this research study is to assess hormone withdrawal symptoms in women while taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in comparison to taking pills in the standard 21/7 (21 "real" pills) manner.

It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms compared to the standard 21/7 regimen.

It is further hypothesized that women using the 24/4 regimen will report greater satisfaction scores.

Conditions

Interventions

DRUG

loestrin 24/4 vs loestrin 1/20

One month of loestrin 1/20 then randomized to Loestrin 24/4 or Loestrin 1/20 x 3 months. After 3 months if randomized to 1/20 will be switched to 24/4 if already on 24/4 will be given a choice which OC they want to continue for 3 more months.

DRUG

loestrin 1/20

loestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE

Sponsors & Collaborators

  • Warner Chilcott

    collaborator INDUSTRY

  • Scott and White Hospital & Clinic

    lead OTHER

Principal Investigators

  • Patricia Sulak, MD · Scott and White Hospital & Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00475189 on ClinicalTrials.gov