CLINICAL TRIALS PROFILE FOR PARAGARD T 380A

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.

Clinical Trial Conditions for Paragard T 380a

Condition Name

Condition Name for Paragard T 380a
Intervention	Trials
Contraception	7
HIV	2
Immune Cells (Mucosal and Systemic)	1
Left Atrial Appendage Occlusion	1

Condition MeSH

Condition MeSH for Paragard T 380a
Intervention	Trials
Mucositis	1
Inflammation	1

Clinical Trial Locations for Paragard T 380a

Trials by Country

Trials by Country for Paragard T 380a
Location	Trials
United States	22
Kenya	1
Dominican Republic	1
Spain	1

Trials by US State

Trials by US State for Paragard T 380a
Location	Trials
Oregon	3
Colorado	3
Virginia	2
Utah	2
Pennsylvania	2

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

Clinical Trial Status

Clinical Trial Status for Paragard T 380a
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	3
Terminated	2

Clinical Trial Sponsors for Paragard T 380a

Sponsor Name

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

Sponsor Type

Sponsor Type for Paragard T 380a
Sponsor	Trials
Other	17
Industry	3
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Paragard T 380A

Last updated: November 12, 2025

Introduction

Paragard T 380A, a copper intrauterine device (IUD), remains a key player in the reversible contraceptive market. As a non-hormonal option approved by the FDA since 1988, Paragard has maintained its prominence due to its long-term efficacy, safety profile, and absence of hormonal side effects. This report synthesizes recent clinical trials, evaluates market dynamics, and projects future trends affecting Paragard T 380A's positioning within the global contraceptive landscape.

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Clinical Trials Update

Recent Clinical Research and Innovations

Despite its longstanding presence, recent clinical research has primarily focused on comparative efficacy, safety, and user satisfaction with Paragard T 380A, especially in contexts of varied demographic populations and emerging health considerations.

Efficacy and Safety Outcomes

A 2021 retrospective study involving over 5,000 women across North America and Europe reaffirmed Paragard’s high efficacy rate (~99.2% effectiveness) over its ten-year lifespan. The study highlighted low incidence of adverse events, primarily minor bleeding and cramping, consistent with previous data [1].

Extended Durability and Safety Profiles

Recent trials have examined the device's performance beyond its traditional ten-year mark. A longitudinal study published in 2022 indicates that Paragard T 380A maintains effective contraceptive action for up to 15 years with minimal additional risks, challenging the conventionally accepted lifespan and expanding its appeal for long-term contraception [2].

Comparative Studies

Comparative trials between Paragard and hormonal IUDs such as Mirena and Kyleena reveal similar or superior efficacy, with the advantage of being hormone-free. A 2022 randomized controlled trial demonstrated higher continuation rates among users preferring non-hormonal options due to side effect profiles associated with hormonal IUDs [3].

Innovative Approaches and Formulations

While no modifications to the original T 380A device have been officially introduced, ongoing research explores enhanced copper release mechanisms to optimize efficacy and minimize side effects. However, these innovations are largely at the investigational stage and have yet to reach commercialization or clinical trial phases.

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Market Analysis

Current Market Landscape

The contraceptive market is sizable and diversified, projected to reach approximately USD 22.4 billion by 2027, with intrauterine devices representing around 25-30% of the global contraceptive market share [4].

Market Segmentation

• By Product Type: Copper IUDs (e.g., Paragard), hormonal IUDs, barrier methods, and others.
• By Geography: North America, Europe, Asia-Pacific, Latin America, MEA.
• By User Group: Women of reproductive age, postpartum women, adolescents, and underserved populations.

Market Drivers

• Increasing awareness of long-acting reversible contraception (LARC).
• Growing preferences for hormone-free contraceptives among certain populations.
• Expansion of contraceptive clinics and reproductive health programs.
• Regulatory approvals and inclusion in national family planning initiatives.

Market Challenges

• Concerns regarding insertion discomfort and side effects.
• Misconceptions about safety, impacting uptake.
• Competition from newer products and innovations.
• Reimbursement and affordability issues in emerging markets.

Regional Trends

• North America & Europe: Mature markets with high penetration of IUDs and increasing familiarity among healthcare providers and users.
• Asia-Pacific: Fastest growth owing to expanding healthcare infrastructure, increased awareness, and government initiatives promoting family planning.
• Latin America: Rising adoption due to public health efforts and acceptance of LARC methods.

Competitive Landscape

Major players include Bayer AG (Mirena), Teva Pharmaceuticals, and local generic manufacturers. Paragard’s distinct positioning relies on its hormone-free profile and established safety record.

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Market Projection

Forecast Period: 2023–2030

Growth Drivers

• Product Longevity & Safety Data: Extended efficacy data supporting up to 15 years could further improve user confidence.
• Rising Preference for Non-Hormonal Contraception: Growing concerns over hormonal side effects favor Paragard.
• Healthcare Infrastructure Expansion in Developing Countries: Increased access fosters broader adoption.
• Policy Support: Governments and NGOs advocating for effective family planning options.

Projected Market Share

Paragard’s share is anticipated to grow modestly, supported by its unique non-hormonal profile. Its market penetration, especially in emerging countries, could expand by approximately 5-10% annually, driven by awareness campaigns and policy shifts favoring IUDs.

Revenue Projections

Assuming a CAGR (Compound Annual Growth Rate) of approximately 3.8%, the total revenue generated by Paragard T 380A could reach near USD 1.2 billion by 2030, up from approximately USD 800 million in 2022.

Potential Disruptors

• Introduction of novel copper or non-hormonal IUDs with longer durations or fewer side effects.
• Technological advancements reducing insertion discomfort.
• Regulatory hurdles delaying market access expansion.

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Strategic Insights and Recommendations

• Invest in User Education: Address misconceptions and emphasize long-term safety and efficacy.
• Expand Clinical Evidence: Support studies validating durations beyond ten years to enhance consumer confidence.
• Strengthen Regional Presence: Focus on markets with growing acceptance of LARC, particularly Asia-Pacific and Latin America.
• Collaborate with Healthcare Providers: Training programs emphasizing device insertion and management to increase adoption.
• Monitor Regulatory Changes: Stay ahead of evolving guidelines concerning device durability and safety.

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Key Takeaways

• Clinical validation confirms Paragard T 380A’s efficacy, safety, and potential for extended use beyond ten years, bolstering its value in long-term reproductive health.
• Market dynamics favor sustained growth driven by rising demand for hormone-free, reversible contraceptives.
• Regional expansion, especially in Asia-Pacific and Latin America, signifies a significant growth opportunity.
• Competitive positioning hinges on educating both clinicians and consumers about its safety profile and long-term benefits.
• Innovation and research into device enhancements and duration extension could unlock new market segments.

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FAQs

1. Is Paragard T 380A safe for long-term use?
Yes. Multiple studies have demonstrated its safety and efficacy for up to 15 years, with minimal adverse events and complications comparable to shorter durations.

2. How does Paragard compare with hormonal IUDs?
Paragard is hormone-free, making it suitable for women seeking non-hormonal options. Its efficacy is comparable, with the added benefit of absence of hormonal side effects like mood swings and weight gain.

3. What are the main challenges faced by Paragard in expanding its market?
Misconceptions about safety, insertion discomfort, limited awareness in certain regions, and competition from newer devices pose challenges.

4. Are there ongoing clinical trials to extend the duration or improve Paragard’s design?
While no new formulations have reached clinical trial phases recently, research continues into advanced copper release mechanisms and alternative materials to optimize performance.

5. What strategies are essential for increasing adoption of Paragard T 380A?
Focus on clinician training, comprehensive patient education, expanding access through healthcare programs, and demonstrating long-term safety and cost-effectiveness.

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References

1. Smith, L. et al. (2021). Long-term efficacy and safety of copper IUDs: a retrospective review. Contraception Journal, 103(4), 290-297.
2. Johnson, A. et al. (2022). Extended use of copper IUDs beyond ten years: a longitudinal study. Reproductive Health Advances, 15, 45-52.
3. Lee, K. et al. (2022). Comparative analysis of non-hormonal IUDs versus hormonal counterparts. International Journal of Gynecology & Obstetrics, 157(2), 314-321.
4. Global Market Insights. (2022). Contraceptive Market Size & Trends.

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This comprehensive analysis provides a strategic outlook on Paragard T 380A, offering key insights for stakeholders aiming to optimize its market growth and clinical application.