Pelvic PainNCT00475189
Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)
A study testing loestrin 24/4 vs loestrin 1/20 and loestrin 1/20 in people with Pelvic Pain and Headaches, run by Scott and White Hospital & Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Headaches, Emotional
- What is being tested?
- loestrin 24/4 vs loestrin 1/20 and loestrin 1/20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott & White Hospital and Clinic
Temple, Texas, 76508
About this study
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.
Read the 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.
- Conditions
- Pelvic Pain, Headaches, Emotional
- Being tested
- loestrin 24/4 vs loestrin 1/20, loestrin 1/20
- Keywords
- birth control, PMS, headaches, mood swings, pelvic pain
- Medical subject headings
- Pelvic Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loestrin 24/4 vs loestrin 1/20Drug
Also called Brand name for Loestrin FE 1/20 is Junel FE and Microgestin FE.
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.
loestrin 1/20Drug
Also called Junel FE, Microgestin FE
loestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: loestrin 24/4 vs loestrin 1/20 |
| II | Active comparator | loestrin 1/20 given 1 tab 21/7 Receives: Drug: loestrin 1/20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one month
Secondary outcomes (1)
satisfaction Surveys
Measured: given midway through the study and at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Warner Chilcott
- Investigators
- Patricia Sulak, MD, Principal investigator, Scott and White Hospital & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475189
- Sponsor's protocol ID
- 60783
- Status last verified
- Jul 2011
- First submitted
- 16 May 2007
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Hormone Withdrawal Symptoms of a 24/4 Regimen With a 21/7 Regimen of OC
- ClinicalTrials.gov ID
- NCT00475189
- Acronym / sponsor ID
- 60783
- Conditions
- Pelvic Pain, Headaches, Emotional
- Keywords
- birth control, PMS, headaches, mood swings, pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Collaborators
- Warner Chilcott
- Study start
- Jun 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: loestrin 24/4 vs loestrin 1/20 |
| II | Active comparator | Drug: loestrin 1/20loestrin 1/20 given 1 tab 21/7 |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loestrin 24/4 vs loestrin 1/20Also: Brand name for Loestrin FE 1/20 is Junel FE and Microgestin FE.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. | Drug | 1 |
| loestrin 1/20Also: Junel FE, Microgestin FEloestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE | Drug | II |
Primary outcome
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
1 secondary outcome
satisfaction Surveys
Time frame: given midway through the study and at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Sulak, MD principal investigator
Scott and White Hospital & Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing loestrin 24/4 vs loestrin 1/20 and loestrin 1/20 in people with Pelvic Pain and Headaches, run by Scott and White Hospital & Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.