Pelvic Pain Clinical Trial
Official title:
Prospective Comparison of Hormone Withdrawal Symptoms of a 24/4 Regimen With a 21/7 Regimen of OC
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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