Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)
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.
|Pelvic Pain Headaches Emotional||Drug: loestrin 24/4 vs loestrin 1/20 Drug: loestrin 1/20|
|Study Design:||Allocation: Randomized
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|
- 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 ]
- 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 ]
- satisfaction Surveys [ Time Frame: given midway through the study and at the end of the study ]
|Study Start Date:||June 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
|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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00475189
|United States, Texas|
|Scott & White Hospital and Clinic|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Patricia Sulak, MD||Scott and White Hospital & Clinic|