Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)
|ClinicalTrials.gov Identifier: NCT00475189|
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : July 25, 2011
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|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475189
|United States, Texas|
|Scott & White Hospital and Clinic|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Patricia Sulak, MD||Scott and White Hospital & Clinic|