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

This study has been completed.
Sponsor:
Collaborator:
Warner Chilcott
Information provided by:
Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT00475189
First received: May 16, 2007
Last updated: July 22, 2011
Last verified: July 2011
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

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
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

  Show Detailed Description

  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 & Clinic
  More Information

No publications provided

Responsible Party: Dr. Patricia Sulak, Scott and White Hospital
ClinicalTrials.gov Identifier: NCT00475189     History of Changes
Other Study ID Numbers: 60783
Study First Received: May 16, 2007
Last Updated: July 22, 2011
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:
Headache
Pelvic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Norinyl
Ethynylestradiol mixture with norethindrone
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on April 23, 2014