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

Sponsor:	Scott and White Hospital & Clinic
Collaborator:	Warner Chilcott
Information provided by:	Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:	NCT00475189

Purpose

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.

Condition	Intervention
Pelvic Pain Headaches Emotional	Drug: loestrin 24/4 vs loestrin 1/20 Drug: loestrin 1/20

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	Prospective Comparison of Hormone Withdrawal Symptoms of a 24/4 Regimen With a 21/7 Regimen of OC

Resource links provided by NLM:

MedlinePlus related topics: Headache Pelvic Pain

Drug Information available for: Modicon Ethinyl estradiol mixture with norethindrone Norinyl

U.S. FDA Resources

Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:

Use of the Scott and White (S&W) Daily Symptoms Calendar, which records patient's subjective rating of mood, pelvic pain, flow, headache, and number and dose of pain medicines taken. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Measuring the levels of endogenous hormone (estradiol) in order to correlate serum estradiol levels with withdrawal symptoms during and after the two OC types (4-days versus 7-days) of hormone free intervals. [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

satisfaction Surveys [ Time Frame: given midway through the study and at the end of the study ] [ Designated as safety issue: No ]

Enrollment:	51
Study Start Date:	June 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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.
II: Active Comparator loestrin 1/20 given 1 tab 21/7	Drug: loestrin 1/20 loestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE

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Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

current users (>2 months) of a combination hormonal contraceptive (OC, contraceptive ring, contraceptive patch) with at least the most recent cycle ending with a 7 day HFI
age 18-48
BMI of 40 or less
not desiring to become pregnant during the study time (about 8 months)
capable and reliable in regards to recording and maintaining a daily symptoms log

Exclusion Criteria:

a condition which will not allow you to use combination hormonal contraception; including a past or present history of diabetes, high blood pressure, stroke, breast cancer, heart attacks, blood clots, liver disease, or systemic lupus erythematosus.
are pregnant or plan to become pregnant in the next 8 months or while you are in the study.
a smoker greater than or equal to 35 years of age. You smoke 10 or more cigarettes a day and you are under the age of 35.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475189

Locations

United States, Texas
Scott & White Hospital and Clinic
Temple, Texas, United States, 76508

Sponsors and Collaborators

Scott and White Hospital & Clinic

Warner Chilcott

Investigators

Principal Investigator:

Patricia Sulak, MD

Scott and White Hospital and Clinic

More Information

No publications provided

Responsible Party:	Scott and White Hospital ( Dr. Patricia Sulak )
Study ID Numbers:	60783
Study First Received:	May 16, 2007
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00475189 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Scott and White Hospital & Clinic:

birth control
PMS
headaches
mood swings
pelvic pain

Additional relevant MeSH terms:

Modicon
Contraceptive Agents
Physiological Effects of Drugs
Nervous System Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Pain
Reproductive Control Agents
Norinyl
Pharmacologic Actions

Contraceptives, Oral, Combined
Contraceptives, Oral, Sequential
Signs and Symptoms
Pelvic Pain
Contraceptives, Oral, Hormonal
Therapeutic Uses
Headache
Contraceptives, Oral, Synthetic
Neurologic Manifestations

ClinicalTrials.gov processed this record on November 27, 2009