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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475189
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : July 25, 2011
Warner Chilcott
Information provided by:
Scott and White Hospital & Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Pain Headaches Emotional Drug: loestrin 24/4 vs loestrin 1/20 Drug: loestrin 1/20 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Comparison of Hormone Withdrawal Symptoms of a 24/4 Regimen With a 21/7 Regimen of OC
Study Start Date : June 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Binovum

Arm Intervention/treatment
Active Comparator: 1 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.
Other Name: Brand name for Loestrin FE 1/20 is Junel FE and Microgestin FE.

Active Comparator: II
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
Other Names:
  • Junel FE
  • Microgestin FE

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. satisfaction Surveys [ Time Frame: given midway through the study and at the end of the study ]

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475189

United States, Texas
Scott & White Hospital and Clinic
Temple, Texas, United States, 76508
Sponsors and Collaborators
Scott and White Hospital & Clinic
Warner Chilcott
Principal Investigator: Patricia Sulak, MD Scott and White Hospital & Clinic

Responsible Party: Dr. Patricia Sulak, Scott and White Hospital Identifier: NCT00475189     History of Changes
Other Study ID Numbers: 60783
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Keywords provided by Scott and White Hospital & Clinic:
birth control
mood swings
pelvic pain

Additional relevant MeSH terms:
Pelvic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists