MedTrace Logo

Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®

NCT00475553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2009-12-18

No results posted yet for this study

Summary

The purpose of this research study is to evaluate the best way to manage breakthrough spotting and bleeding during an extended use regimen of NuvaRing®. Ease of use and acceptability of a flexible regimen of NuvaRing® will also be evaluated. A comparison of cyclic mood symptoms, pelvic pain, and headaches will be made between a standard 21/7 regimen and an extended regimen.

Conditions

  • Breakthrough Bleeding
  • Breakthrough Spotting

Interventions

OTHER

remove ring if bleeding or spotting occurs more than 5 days

Both groups of women will be using the nuvaring continuously, ie if the ring is placed on 3rd of January, on the 3rd of February the ring would be removed and a new one inserted. On the 3rd of March the same thing would happen and so forth. Group 2 if bleeding or spotting occurs for more than 5 days then on the 6th day the ring is removed and will keep it out for three more days and reinsert the same ring on the 4th day.

OTHER

If bleeding does not remove ring

Subject is using the nuvaring continuously. For example she puts the ring in on 3rd of January then the 3rd of February is when that ring is removed and another one is inserted. The 3rd of March the same thing occurs.

Sponsors & Collaborators

  • Organon

    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
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00475553 on ClinicalTrials.gov