BleedingNCT01730911
Quick Start Insertion of Mirena and ParaGard
A study testing Text message in people with Bleeding and Cramping, run by Columbia University at 1 site in United States.
Trial summary
Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of women in the US report using them. Women must often wait for their menses to start, or for results of screening for sexually transmitted infections (STIs), before their doctors will place IUDs for them. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bleeding, Cramping, Pregnancy With IUD in Place
- What is being tested?
- Text message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Receiving Mirena or ParaGard intrauterine device for contraception
- Speak English or Spanish
Who cannot join
- Do not use a cell phone
- Unable/unwilling to fill out daily bleeding diaries
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Quick Start Insertion of Mirena and ParaGard Intrauterine Contraceptive Devices
Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of women in the US report using them. Women must often wait for their menses to start, or for results of screening for sexually transmitted infections (STIs), before their doctors will place IUDs for them. This is not the case with other birth control methods. Researchers know that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on the same day of a doctor's visit. In the investigators clinical practice, the investigators often place IUDs on the same day of a woman's visit, but outcomes have not been formally assessed.
Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if women who have IUDs placed at any time during their menstrual cycle have different experiences regarding the following, compared to those who have IUDS placed during the first 7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming pregnant more often during that first cycle (window pregnancy).
Read more
Women who come to their provider seeking an IUD for birth control will be asked to participate in this study. The investigators will ask them to keep track of their bleeding and cramping for three subsequent months to see if patterns differ according to the day in their menstrual cycle that the device was inserted. They will be randomly assigned either to record this information on paper, or to send in the information by responding to daily text messages.
The investigators want to know if women who have an IUD placed at any time during the menstrual cycle have different outcomes compared to those who have IUDs placed during the first 7 days of their cycle. If the investigators have this information, the investigators can make recommendations to physicians, help counsel patients, and potentially expand access to IUDs.
Read the detailed description
- STUDY PURPOSE AND RATIONALE Intrauterine devices (IUDs) are an effective yet underutilized form of contraception in the United States. Only 5.5% of women age 15-44 reported using them in 2006-2008(Mosher 2010). Due to historical practices or prescribing recommendations, IUD insertion may be delayed if women must wait for results of screening for sexually transmitted infections (STIs) or for the beginning of their menstrual cycle. Such barriers are not as prevalent for other contraceptive methods. Initiation of oral contraceptive pills (OCPs), the vaginal ring, transdermal patches, and depot medroxyprogesterone acetate injection, with emergency contraception (EC) as indicated, is safely done on the same day of a woman's visit to her provider. This "Quick Start" approach improves access to birth control and has been well studied at the Family Planning Clinic at Columbia Presbyterian Medical Center and at other institutions (Westhoff 2002, Schafer 2006, Murthy 2005, Rickert 2007). The investigators providers often extend this practice to IUD insertion, but outcomes have not been formally assessed. If the investigators can show that insertion at any time is safe, the investigators can improve access.
There are several concerns surrounding IUD insertion at the time of an initial visit to a health care provider. One problem with insertion outside the first week of the menstrual cycle may be "window" pregnancies those that occur during the first cycle with the IUD in place. For OCPs initiated with the Quick Start protocol, the pregnancy rate is approximately 2% (Westhoff 2007). No data exist for IUDs that insertion during any other part of the cycle differs with regard to number of window pregnancies. Another theoretical drawback to immediate IUD initiation is insertion in the setting of an undiagnosed STI. While the risk of developing pelvic inflammatory disease (PID) is highest in the 20 days postinsertion, the incidence of pelvic inflammatory disease among IUD users is rare and estimated at between 1:100 to 1:1,000 woman-years (Martinez 2009). Evidence does not support routine screening for sexually transmitted infections prior to IUD insertion for women at low risk for STIs, and testing should be done based on local prevalence data (Walsh 1998; Skjeldestad 1996). For women younger than 26 or with multiple sex partners, screening can be done on the same day of insertion. However, variation in individual provider practice patterns can be an additional barrier that delays IUD insertion and puts women at risk for interval pregnancies while awaiting IUD insertion.
Alterations in cramping, expulsions, and bleeding patterns may or may not be associated with cycle day of insertion but nonetheless could contribute to satisfaction with and continuation rates of the IUD. In a 60 month study of TCu380A IUDs in Iran, approximately 25% of women discontinued the method due to bleeding and pain (Jenabi 2006). Another study done in Kuwait found that irregular or heavy bleeding was a common complaint (Alnakash 2008). Published data on these issues is sparse. Without evidence that alternatives are safe for the two IUDs that are currently available, physicians may be reluctant to individualize.
An accurate assessment of bleeding patterns after IUD insertion rests on the quality of data gathered. In 2005, Mishell issued guidelines for standardization of data collection and analysis of bleeding patterns for combined hormone contraceptive trials, and noted the need for prospective comparative studies of the accuracy of electronic data collection versus paper diaries (Mishell, 2005). There are no published data comparing the quality and quantity of information obtained using these two methods, but text messages are increasingly used to collect data in clinical trials. This study affords us the opportunity to compare this new modality with existing methods.
- Conditions
- Bleeding, Cramping, Pregnancy With IUD in Place, IUD Expulsion, IUD Removal
- Being tested
- Text message
- Keywords
- Bleeding, Cramping, Pregnancy with intrauterine device in place, Intrauterine device expulsion, Intrauterine device removal
- Medical subject headings
- Hemorrhage, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messageOther
Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.
| Study group | Role | What they receive |
|---|---|---|
| ParaGard, paper diaries | No intervention | Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries on paper. |
| ParaGard, text message | Active comparator | Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries via text message. Receives: Other: Text message |
| Mirena, paper diaries | No intervention | Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries on paper. |
| Mirena, text message | Active comparator | Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries via text message. Receives: Other: Text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding and cramping days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Paula Castano, Columbia University
- Investigators
- Paula Castaño, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730911
- Sponsor's protocol ID
- AAAJ3059
- Status last verified
- Sep 2014
- First submitted
- 16 Nov 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Alnakash AH. Influence of IUD perceptions on method discontinuation. Contraception. 2008 Oct;78(4):290-3. doi: 10.1016/j.contraception.2008.05.009. Epub 2008 Jul 30.
PubMed 18847576Belsey EM, Carlson N. The description of menstrual bleeding patterns: towards fewer measures. Stat Med. 1991 Feb;10(2):267-84. doi: 10.1002/sim.4780100210.
PubMed 2052804Castano PM, Bynum JY, Andres R, Lara M, Westhoff C. Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):14-20. doi: 10.1097/AOG.0b013e31823d4167.
PubMed 22143257Jenabi E, Alizade SM, Baga RI. Continuation rates and reasons for discontinuing TCu380A IUD use in Tabriz, Iran. Contraception. 2006 Dec;74(6):483-6. doi: 10.1016/j.contraception.2006.08.007. Epub 2006 Oct 13.
PubMed 17157106Martinez F, Lopez-Arregui E. Infection risk and intrauterine devices. Acta Obstet Gynecol Scand. 2009;88(3):246-50. doi: 10.1080/00016340802707473.
PubMed 19172421Mishell DR Jr, Guillebaud J, Westhoff C, Nelson AL, Kaunitz AM, Trussell J, Davis AJ. Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials. Contraception. 2007 Jan;75(1):11-5. doi: 10.1016/j.contraception.2006.08.012. Epub 2006 Oct 11.
PubMed 17161117Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
PubMed 20939159Murthy AS, Creinin MD, Harwood B, Schreiber CA. Same-day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods. Contraception. 2005 Nov;72(5):333-6. doi: 10.1016/j.contraception.2005.05.009. Epub 2005 Aug 9.
PubMed 16246657Rickert VI, Tiezzi L, Lipshutz J, Leon J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8. doi: 10.1016/j.jadohealth.2006.10.018.
PubMed 17185202Schafer JE, Osborne LM, Davis AR, Westhoff C. Acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive. Contraception. 2006 May;73(5):488-92. doi: 10.1016/j.contraception.2005.11.003. Epub 2006 Jan 3.
PubMed 16627032Skjeldestad FE, Halvorsen LE, Kahn H, Nordbo SA, Saake K. IUD users in Norway are at low risk for genital C. trachomatis infection. Contraception. 1996 Oct;54(4):209-12. doi: 10.1016/s0010-7824(96)00190-4.
PubMed 8922873Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Coulson A, Bernstein G. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet. 1998 Apr 4;351(9108):1005-8. doi: 10.1016/s0140-6736(97)09086-7.
PubMed 9546505Westhoff C, Kerns J, Morroni C, Cushman LF, Tiezzi L, Murphy PA. Quick start: novel oral contraceptive initiation method. Contraception. 2002 Sep;66(3):141-5. doi: 10.1016/s0010-7824(02)00351-7.
PubMed 12384200Westhoff C, Heartwell S, Edwards S, Zieman M, Cushman L, Robilotto C, Stuart G, Morroni C, Kalmuss D. Initiation of oral contraceptives using a quick start compared with a conventional start: a randomized controlled trial. Obstet Gynecol. 2007 Jun;109(6):1270-6. doi: 10.1097/01.AOG.0000264550.41242.f2.
PubMed 17540797Nippita S, Modest AM, Westhoff CL, Castano PM, Oviedo J, Rivlin K. Bleeding and Cramping in the First 90 Days After Copper or Levonorgestrel Intrauterine Device Placement. Perspect Sex Reprod Health. 2026 Sep 7. doi: 10.1111/psrh.70088. Online ahead of print.
PubMed 42705661
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quick Start Insertion of Mirena and ParaGard Intrauterine Contraceptive Devices
- ClinicalTrials.gov ID
- NCT01730911
- Acronym / sponsor ID
- AAAJ3059
- Conditions
- Bleeding, Cramping, Pregnancy With IUD in Place, IUD Expulsion, IUD Removal
- Keywords
- Bleeding, Cramping, Pregnancy with intrauterine device in place, Intrauterine device expulsion, Intrauterine device removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Nov 2012 (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.
Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of women in the US report using them. Women must often wait for their menses to start, or for results of screening for sexually transmitted infections (STIs), before their doctors will place IUDs for them. This is not the case with other birth control methods. Researchers know that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on the same day of a doctor's visit. In the investigators clinical practice, the investigators often place IUDs on the same day of a woman's visit, but outcomes have not been formally assessed.
Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if women who have IUDs placed at any time during their menstrual cycle have different experiences regarding the following, compared to those who have IUDS placed during the first 7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming pregnant more often during that first cycle (window pregnancy).
Women who come to their provider seeking an IUD for birth control will be asked to participate in this study. The investigators will ask them to keep track of their bleeding and cramping for three subsequent months to see if patterns differ according to the day in their menstrual cycle that the device was inserted. They will be randomly assigned either to record this information on paper, or to send in the information by responding to daily text messages.
The investigators want to know if women who have an IUD placed at any time during the menstrual cycle have different outcomes compared to those who have IUDs placed during the first 7 days of their cycle. If the investigators have this information, the investigators can make recommendations to physicians, help counsel patients, and potentially expand access to IUDs.
Detailed description
- STUDY PURPOSE AND RATIONALE Intrauterine devices (IUDs) are an effective yet underutilized form of contraception in the United States. Only 5.5% of women age 15-44 reported using them in 2006-2008(Mosher 2010). Due to historical practices or prescribing recommendations, IUD insertion may be delayed if women must wait for results of screening for sexually transmitted infections (STIs) or for the beginning of their menstrual cycle. Such barriers are not as prevalent for other contraceptive methods. Initiation of oral contraceptive pills (OCPs), the vaginal ring, transdermal patches, and depot medroxyprogesterone acetate injection, with emergency contraception (EC) as indicated, is safely done on the same day of a woman's visit to her provider. This "Quick Start" approach improves access to birth control and has been well studied at the Family Planning Clinic at Columbia Presbyterian Medical Center and at other institutions (Westhoff 2002, Schafer 2006, Murthy 2005, Rickert 2007). The investigators providers often extend this practice to IUD insertion, but outcomes have not been formally assessed. If the investigators can show that insertion at any time is safe, the investigators can improve access.
There are several concerns surrounding IUD insertion at the time of an initial visit to a health care provider. One problem with insertion outside the first week of the menstrual cycle may be "window" pregnancies those that occur during the first cycle with the IUD in place. For OCPs initiated with the Quick Start protocol, the pregnancy rate is approximately 2% (Westhoff 2007). No data exist for IUDs that insertion during any other part of the cycle differs with regard to number of window pregnancies. Another theoretical drawback to immediate IUD initiation is insertion in the setting of an undiagnosed STI. While the risk of developing pelvic inflammatory disease (PID) is highest in the 20 days postinsertion, the incidence of pelvic inflammatory disease among IUD users is rare and estimated at between 1:100 to 1:1,000 woman-years (Martinez 2009). Evidence does not support routine screening for sexually transmitted infections prior to IUD insertion for women at low risk for STIs, and testing should be done based on local prevalence data (Walsh 1998; Skjeldestad 1996). For women younger than 26 or with multiple sex partners, screening can be done on the same day of insertion. However, variation in individual provider practice patterns can be an additional barrier that delays IUD insertion and puts women at risk for interval pregnancies while awaiting IUD insertion.
Alterations in cramping, expulsions, and bleeding patterns may or may not be associated with cycle day of insertion but nonetheless could contribute to satisfaction with and continuation rates of the IUD. In a 60 month study of TCu380A IUDs in Iran, approximately 25% of women discontinued the method due to bleeding and pain (Jenabi 2006). Another study done in Kuwait found that irregular or heavy bleeding was a common complaint (Alnakash 2008). Published data on these issues is sparse. Without evidence that alternatives are safe for the two IUDs that are currently available, physicians may be reluctant to individualize.
An accurate assessment of bleeding patterns after IUD insertion rests on the quality of data gathered. In 2005, Mishell issued guidelines for standardization of data collection and analysis of bleeding patterns for combined hormone contraceptive trials, and noted the need for prospective comparative studies of the accuracy of electronic data collection versus paper diaries (Mishell, 2005). There are no published data comparing the quality and quantity of information obtained using these two methods, but text messages are increasingly used to collect data in clinical trials. This study affords us the opportunity to compare this new modality with existing methods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ParaGard, paper diaries | No intervention | –Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries on paper. |
| ParaGard, text message | Active comparator | Other: Text messageWomen who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries via text message. |
| Mirena, paper diaries | No intervention | –Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries on paper. |
| Mirena, text message | Active comparator | Other: Text messageWomen who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries via text message. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving Mirena or ParaGard intrauterine device for contraception
- Speak English or Spanish
Key exclusion criteria (2 listed)
- Do not use a cell phone
- Unable/unwilling to fill out daily bleeding diaries
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 |
|---|---|---|
| Text messageParticipants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm. | Other | Mirena, text message, ParaGard, text message |
Primary outcome
Number of bleeding and cramping days
Time frame: 3 months
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 Sep 2014.
- Background: PubMed 18847576Alnakash AH. Influence of IUD perceptions on method discontinuation. Contraception. 2008 Oct;78(4):290-3. doi: 10.1016/j.contraception.2008.05.009. Epub 2008 Jul 30.
- Background: PubMed 2052804Belsey EM, Carlson N. The description of menstrual bleeding patterns: towards fewer measures. Stat Med. 1991 Feb;10(2):267-84. doi: 10.1002/sim.4780100210.
- Background: PubMed 22143257Castano PM, Bynum JY, Andres R, Lara M, Westhoff C. Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):14-20. doi: 10.1097/AOG.0b013e31823d4167.
- Background: PubMed 17157106Jenabi E, Alizade SM, Baga RI. Continuation rates and reasons for discontinuing TCu380A IUD use in Tabriz, Iran. Contraception. 2006 Dec;74(6):483-6. doi: 10.1016/j.contraception.2006.08.007. Epub 2006 Oct 13.
- Background: PubMed 19172421Martinez F, Lopez-Arregui E. Infection risk and intrauterine devices. Acta Obstet Gynecol Scand. 2009;88(3):246-50. doi: 10.1080/00016340802707473.
- Background: PubMed 17161117Mishell DR Jr, Guillebaud J, Westhoff C, Nelson AL, Kaunitz AM, Trussell J, Davis AJ. Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials. Contraception. 2007 Jan;75(1):11-5. doi: 10.1016/j.contraception.2006.08.012. Epub 2006 Oct 11.
- Background: PubMed 20939159Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
- Background: PubMed 16246657Murthy AS, Creinin MD, Harwood B, Schreiber CA. Same-day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods. Contraception. 2005 Nov;72(5):333-6. doi: 10.1016/j.contraception.2005.05.009. Epub 2005 Aug 9.
- Background: PubMed 17185202Rickert VI, Tiezzi L, Lipshutz J, Leon J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8. doi: 10.1016/j.jadohealth.2006.10.018.
- Background: PubMed 16627032Schafer JE, Osborne LM, Davis AR, Westhoff C. Acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive. Contraception. 2006 May;73(5):488-92. doi: 10.1016/j.contraception.2005.11.003. Epub 2006 Jan 3.
- Background: PubMed 8922873Skjeldestad FE, Halvorsen LE, Kahn H, Nordbo SA, Saake K. IUD users in Norway are at low risk for genital C. trachomatis infection. Contraception. 1996 Oct;54(4):209-12. doi: 10.1016/s0010-7824(96)00190-4.
- Background: PubMed 9546505Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Coulson A, Bernstein G. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet. 1998 Apr 4;351(9108):1005-8. doi: 10.1016/s0140-6736(97)09086-7.
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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.
Paula Castaño, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message in people with Bleeding and Cramping, run by Columbia University 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 2 inclusion and 2 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 Sep 2014. 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?
Number of bleeding and cramping days (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730911, which also lists 15 linked publications.
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 Sep 2014.