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Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)
This study has been completed.
First Received: May 16, 2007   Last Updated: June 3, 2009   History of Changes
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:


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

  Hide Detailed Description

Detailed Description:

Women who will be considered for this study are those who are presently taking combination estrogen/progestin contraception for at least 2 months. They must be between the ages of 18 and 48 years with a body mass index of 40 or less. Study participants will be asked to keep a daily diary of symptoms based on the symptoms listed above. This requires ranking the severity of bleeding, pelvic pain, mood, and headaches based on a scale defined on the daily diary. All subjects will keep track of any pain medication that they take on a medication log.

Subjects that are not sure if their symptoms (mood, pelvic pain or headache) increase on days 1-3 and 18-28, will be asked to keep the diary while taking their current contraceptive medication. After they record their symptoms in the diary, it will be evaluated by the study coordinator to see if they qualify (which means that mood, pelvic pain and headache must have increased on days 1-3 and 18-28 compared to days 4-17). If they qualify, visit 1 will be scheduled.

At visit 1, subjects will undergo a physical exam and a pelvic exam. Subjects may be required to have a Pap smear if one has not been performed or if there is not sufficient documentation of one within the past year. Subjects will be given a single pack of Loestrin 1/20 for cycle #1 along with their symptoms calendars and medication log.

All women will begin the study with one month of Loestrin 1/20, to be taken in a normal 21/7 manner, and will complete a daily questionnaire. To continue in the study, subjects must be classified as having substantial fluctuation in their symptoms. At visit 2, (end of cycle #1), subjects will return their completed calendar to the study coordinator. The calendar will be reviewed for compliance and for eligibility based on symptom criteria. Subjects will also be scheduled for lab work. Women who continue in the study will be randomly assigned either to a group to start taking Loestrin 24 Fe (24 real pills and 4 placebo pills - Group 1), or to a group to continue taking Loestrin 1/20 in the standard 21/7 fashion for an additional 3 cycles (Group 2). All women will be asked to continue keeping a daily log of their symptoms, which will be turned in to the study coordinator at each of the scheduled visits.

Subjects will not be given the choice initially as to which group they will be placed; however all women will be given the opportunity to evaluate the 24/4 regimen. After the first 3 randomized cycles (visit 3), subjects will turn in their calendars to the study coordinator. Group 1 will be given a choice between continuing Loestrin 24 Fe or going back to Loestrin 1/20. Group 1 will complete a brief survey regarding their choice and will be given 3 packs of the pill of choice. All Group 2 subjects will be switched onto 3 cycles of Loestrin 24 Fe. Subjects in both groups will continue keeping their daily symptoms calendar.

At visit 4, the end of cycle #5, all subjects will turn in their calendars to the study coordinator.

At visit 5, the end of cycle #7, subjects will turn in their calendars to the study coordinator. All subjects will fill out a questionnaire. Subjects will be evaluated and will be given a prescription for the OC of their choice.

Subjects will also be asked to complete mid-study and end of study quality of life and satisfaction questionnaires.

Blood Draws 1-8 One of the objectives of this study is to compare hormone withdrawal symptoms with actual hormone levels. Measuring hormones requires samples of blood. Over the course of the study, there will be a total of 8 separate blood samples (for a total of approximately 8 teaspoons of blood) to be taken from each subject. Subjects in Group 1 who were randomized to Loestrin 24 Fe during cycles 2 through 4 will start blood sampling on cycle day 24, the last day of active pills in this cycle and continue at three day intervals. Subjects in Group 2 who were randomized to Loestrin 1/20 during cycles 2 through 4 will start blood sampling on cycle day 21, the last day of active pills in the 4th cycle and continue at three day intervals.

  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