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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR CLOMIPHENE CITRATE


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All Clinical Trials for Clomiphene Citrate

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00068861 ↗ Treatment of Infertility in Women With Polycystic Ovary Syndrome Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 2002-11-01 Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women. The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.
NCT00005104 ↗ Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Completed University of Virginia N/A 2000-01-01 OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
NCT00005104 ↗ Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Completed National Center for Research Resources (NCRR) N/A 2000-01-01 OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
NCT00005654 ↗ Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome Completed University of Virginia N/A 2000-01-01 OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.
NCT00005654 ↗ Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome Completed National Center for Research Resources (NCRR) N/A 2000-01-01 OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for Clomiphene Citrate

Condition Name

5950141100102030405060InfertilityPolycystic Ovary SyndromeAnovulationPolycystic Ovarian Syndrome[disabled in preview]
Condition Name for Clomiphene Citrate
Intervention Trials
Infertility 59
Polycystic Ovary Syndrome 50
Anovulation 14
Polycystic Ovarian Syndrome 11
[disabled in preview] 0
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Condition MeSH

8480481900102030405060708090InfertilityPolycystic Ovary SyndromeSyndromeAnovulation[disabled in preview]
Condition MeSH for Clomiphene Citrate
Intervention Trials
Infertility 84
Polycystic Ovary Syndrome 80
Syndrome 48
Anovulation 19
[disabled in preview] 0
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Clinical Trial Locations for Clomiphene Citrate

Trials by Country

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Trials by Country for Clomiphene Citrate
Location Trials
United States 100
Egypt 55
Italy 10
China 9
Pakistan 5
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Trials by US State

+
Trials by US State for Clomiphene Citrate
Location Trials
New York 7
Texas 7
Michigan 6
California 6
Pennsylvania 5
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Clinical Trial Progress for Clomiphene Citrate

Clinical Trial Phase

42.7%23.1%8.5%25.6%0101520253035404550Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Clomiphene Citrate
Clinical Trial Phase Trials
Phase 4 50
Phase 3 27
Phase 2/Phase 3 10
[disabled in preview] 30
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Clinical Trial Status

57.9%19.5%9.8%12.8%0102030405060708090100CompletedUnknown statusNot yet recruiting[disabled in preview]
Clinical Trial Status for Clomiphene Citrate
Clinical Trial Phase Trials
Completed 95
Unknown status 32
Not yet recruiting 16
[disabled in preview] 21
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Clinical Trial Sponsors for Clomiphene Citrate

Sponsor Name

trials0246810121416Cairo UniversityAin Shams UniversityAssiut University[disabled in preview]
Sponsor Name for Clomiphene Citrate
Sponsor Trials
Cairo University 15
Ain Shams University 12
Assiut University 10
[disabled in preview] 14
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Sponsor Type

89.3%6.2%0050100150200250OtherIndustryNIH[disabled in preview]
Sponsor Type for Clomiphene Citrate
Sponsor Trials
Other 243
Industry 17
NIH 8
[disabled in preview] 4
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Clomiphene Citrate: Clinical Trials, Market Analysis, and Projections

Introduction

Clomiphene citrate is a widely used medication for inducing ovulation in women with infertility issues, particularly those with polycystic ovary syndrome (PCOS) or other ovulatory disorders. Here, we will delve into the latest clinical trials, market analysis, and projections for this drug.

Clinical Trials and Safety Concerns

Recent Studies on Fetal Development

A recent study published in the journal Endocrinology highlighted the potential risks associated with clomiphene citrate administration during the periconception phase. The study conducted on mice showed that clomiphene citrate can cause significant adverse effects on fetal development, including reduced viable pregnancy rates, lower fetal weights, and increased congenital abnormalities such as defects in the lung, kidney, liver, eye, skin, limbs, and umbilicus[1].

Pharmacokinetic Studies in Men

Another ongoing clinical trial focuses on the pharmacokinetic evaluation of serum testosterone concentrations after the administration of clomiphene citrate in men with low serum testosterone levels. This randomized, open-label trial aims to analyze the effects of two different doses of clomiphene citrate on testosterone levels, potentially allowing for more flexible dosing regimens[4].

Market Analysis

Global Market Size and Growth

The global clomiphene citrate market has been steadily growing. As of 2023, the market size was valued at approximately $105 million and is projected to reach $128 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 2.8% during the forecast period of 2024-2030[2].

Regional Market Trends

The Asia-Pacific region is expected to be a significant market for clomiphene citrate due to the rising prevalence of infertility in countries such as China, Japan, and Malaysia. This region's market growth is driven by factors like late marriages and declining birth rates[3].

Competitive Landscape

The market is dominated by several key players, including Sanofi S.A., Par Pharmaceutical, Merck & Co. Inc., Teva Pharmaceutical Industries Ltd., and others. These companies play a crucial role in the production and distribution of clomiphene citrate tablets globally[5].

Market Projections

Forecasted Market Size

By 2030, the global clomiphene citrate market is expected to reach $128 million, with a CAGR of 2.8% from 2024 to 2030. This growth is anticipated to be driven by increasing government initiatives to treat infertility and the rising prevalence of PCOS among women[2].

Segment by Type and Application

The market is segmented by type and application, with hospital pharmacies being a significant segment. The report provides detailed forecasts for revenue and volume by type, application, and region, helping businesses develop growth strategies and assess their market position[5].

Regional Growth

North America and Europe are also expected to see growth, although at a slower pace compared to the Asia-Pacific region. The Latin America and Middle East & Africa regions are also projected to contribute to the overall market growth, albeit at a lower rate[5].

Key Trends and Drivers

Government Initiatives

Government initiatives to treat infertility, such as the Ontario Fertility Program in Canada, are expected to drive the growth of the clomiphene citrate market. These programs provide funding for fertility services, making treatments more accessible to a wider population[3].

Prevalence of PCOS

The increasing prevalence of PCOS among reproductive-age women globally is another significant driver. According to the World Health Organization, PCOS affects 8% to 20% of reproductive-age women, making it a major factor in the demand for clomiphene citrate[3].

Conclusion

Clomiphene citrate remains a critical medication for treating infertility, particularly in women with ovulatory disorders. However, recent clinical trials highlight the need for careful consideration of its use during the periconception phase due to potential adverse effects on fetal development.

Key Takeaways

  • Clinical Trials: Recent studies show adverse effects on fetal development when clomiphene citrate is administered during the periconception phase.
  • Market Size: The global market is projected to reach $128 million by 2030, growing at a CAGR of 2.8%.
  • Regional Trends: The Asia-Pacific region is expected to be a significant market due to rising infertility rates.
  • Competitive Landscape: Dominated by key players such as Sanofi S.A. and Merck & Co. Inc.
  • Drivers: Government initiatives and the increasing prevalence of PCOS are key drivers of market growth.

FAQs

What are the potential risks associated with clomiphene citrate use during the periconception phase?

Clomiphene citrate use during the periconception phase has been associated with reduced viable pregnancy rates, lower fetal weights, and increased congenital abnormalities in animal studies[1].

What is the projected market size of clomiphene citrate by 2030?

The global clomiphene citrate market is expected to reach $128 million by 2030, growing at a CAGR of 2.8% from 2024 to 2030[2].

Which regions are expected to drive the growth of the clomiphene citrate market?

The Asia-Pacific region is expected to be a significant driver of market growth due to the rising prevalence of infertility in countries such as China, Japan, and Malaysia[3].

What are the key drivers of the clomiphene citrate market?

Key drivers include government initiatives to treat infertility and the increasing prevalence of PCOS among reproductive-age women globally[3].

Who are the major players in the clomiphene citrate market?

Major players include Sanofi S.A., Par Pharmaceutical, Merck & Co. Inc., Teva Pharmaceutical Industries Ltd., and others[5].

Sources

  1. Clomiphene Citrate Administered in Periconception Phase Causes ... - Academic.oup.com
  2. Global Clomifene Citrate Tablets Market Research Report 2024 - Valuates.com
  3. Global Clomiphene Citrate Market to Surpass US$ 14.51 Million by ... - Businesswire.com
  4. Pharmacokinetic Evaluation of Serum Testosterone Concentrations ... - Centerwatch.com
  5. Global Clomiphene Citrate Market Research Report 2024 - Qyresearch.com

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