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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR PARAGARD T 380A


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All Clinical Trials for PARAGARD T 380A

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01147497 ↗ Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women Completed Emory University N/A 2010-06-01 Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
NCT01422226 ↗ Intra Uterine Device Insertion in Nulliparous Women Terminated University of Colorado, Denver N/A 2011-07-01 Over the last several years, more and more women are choosing intrauterine contraception (IUDs) to meet their birth control needs. The effectiveness of IUDs is very similar to tubal sterilization, with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. Intrauterine contraception has many attributes besides its effectiveness; it is easily reversible, has a low side-effect profile, and provides a long-term solution for contraception (10 years for the copper T380 and 5 years for the levonorgestrel IUD). In addition, using an IUD for birth control requires little on-going effort by the woman to be effective and offers immediate return to fertility with its removal. The biggest increase in users is among nulliparous women (women who have not had children), due to increased awareness of the safety of modern IUDs in this population, and the many benefits of the method. In fact, The copper IUD (Paragard) is now FDA approved for use in nulliparous women, and the American College of Obstetricians and Gynecologists supports the use of both copper and levonorgestrel IUDs in nulliparous women. The cervix of a nulliparous woman has a smaller diameter which can lead to more difficult and uncomfortable IUD insertions. Many providers avoid offering IUDs to nulliparas because of fears that the procedure will be more difficult, and may require cervical dilation, placement of a paracervical nerve block, or placement under ultrasound guidance, none of which are standard for parous women. The medication misoprostol is a prostaglandin E1 analog. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their nulliparous patients a dose of this drug prior to IUD insertion. Misoprostol is commonly used to dilate the cervix for similar procedures as in first trimester abortions, hysteroscopy and endometrial biopsies. Its efficacy in cervical priming for IUD insertion is unknown, and some concern exists that uterine contractions caused by the drug may lead to device expulsion or displacement. In this study, the investigators propose to ask nulliparous women who have undergone contraceptive counseling and decided to use an IUD for birth control to be randomized to the use of misoprostol or placebo prior to their scheduled IUD placement.
NCT01594476 ↗ Early Postpartum Intrauterine Device (IUD) Placement Terminated Society of Family Planning Phase 4 2012-03-01 Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement
NCT01594476 ↗ Early Postpartum Intrauterine Device (IUD) Placement Terminated Oregon Health and Science University Phase 4 2012-03-01 Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement
NCT01664559 ↗ Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement Completed Lynn Ngo N/A 2012-07-01 Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose. It is a strong NSAID that is indicated for the treatment of moderate acute pain. In the intramuscular form it has an analgesia onset of action at 30min, thus may be a plausible option for pain management in the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia and have not been proven to be effective in reducing pain associated with IUD placement. The primary aim of this study is to determine whether ketorolac (Toradol) decreases pain associated with intrauterine device placement compared to placebo. We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD insertion when compared to placebo of normal saline injection.
NCT01873170 ↗ Quantification of Immune Cells in Women Using Contraception (CHIC II) Active, not recruiting University of Pittsburgh 2013-08-01 This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract (including the cervix and the lining of the uterus) of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV. Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women who are not using birth control and who are not at risk of pregnancy for comparison.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PARAGARD T 380A

Condition Name

Condition Name for PARAGARD T 380A
Intervention Trials
Contraception 7
HIV 2
Left Atrial Appendage Occlusion 1
Mucosal Inflammation 1
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Condition MeSH

Condition MeSH for PARAGARD T 380A
Intervention Trials
Mucositis 1
Inflammation 1
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Clinical Trial Locations for PARAGARD T 380A

Trials by Country

Trials by Country for PARAGARD T 380A
Location Trials
United States 22
Spain 1
Kenya 1
Dominican Republic 1
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Trials by US State

Trials by US State for PARAGARD T 380A
Location Trials
Oregon 3
Colorado 3
Utah 2
Pennsylvania 2
California 2
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Clinical Trial Progress for PARAGARD T 380A

Clinical Trial Phase

Clinical Trial Phase for PARAGARD T 380A
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for PARAGARD T 380A
Clinical Trial Phase Trials
Completed 6
Active, not recruiting 3
Terminated 2
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Clinical Trial Sponsors for PARAGARD T 380A

Sponsor Name

Sponsor Name for PARAGARD T 380A
Sponsor Trials
University of Colorado, Denver 2
Society of Family Planning 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
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Sponsor Type

Sponsor Type for PARAGARD T 380A
Sponsor Trials
Other 17
Industry 3
NIH 2
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