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Completed Phase 3 Interventional Accepts healthy volunteers Results available

To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

ClinicalTrials.gov ID: NCT00754065

Public ClinicalTrials.gov record NCT00754065. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 3:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

Study identification

NCT ID
NCT00754065
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
409 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 8, 2008 (Actual)
Primary completion
May 10, 2011 (Actual)
Completion
May 10, 2011 (Actual)
Last update posted
Nov 20, 2024

2008 – 2011

United States locations

U.S. sites
34
U.S. states
20
U.S. cities
32
Facility City State ZIP Site status
Not listed Independence Arizona 94925 —
Not listed Phoenix Arizona 85032 —
Not listed Encinitas California 92024 —
Not listed San Diego California 92108 —
Not listed Santa Monica California 90404 —
Not listed Denver Colorado 80206 —
Not listed Denver Colorado 80218 —
Not listed Littleton Colorado 80127 —
Not listed Clearwater Florida 33759 —
Not listed Jacksonville Florida 32207 —
Not listed West Palm Beach Florida 33409 —
Not listed Decatur Georgia 30034 —
Not listed Boise Idaho 83702 —
Not listed Boise Idaho 83712 —
Not listed Idaho Falls Idaho 83406 —
Not listed Fishers Indiana 46037 —
Not listed Indianapolis Indiana 46217 —
Not listed South Bend Indiana 46601 —
Not listed Metairie Louisiana 70006 —
Not listed Chesterfield Missouri 63017 —
Not listed St Louis Missouri 63141 —
Not listed Lincoln Nebraska 68510 —
Not listed Las Vegas Nevada 89128 —
Not listed New Brunswick New Jersey 08901 —
Not listed Winston-Salem North Carolina 94925 —
Not listed Cincinnati Ohio 45246 —
Not listed Columbus Ohio 43213 —
Not listed Portland Oregon 97239-3011 —
Not listed Philadelphia Pennsylvania 19114 —
Not listed Bristol Tennessee 37620 —
Not listed Memphis Tennessee 38120 —
Not listed Houston Texas 77054 —
Not listed Spokane Washington 99207 —
Not listed La Crosse Wisconsin 54601 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00754065, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 20, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00754065 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →