CLINICAL TRIALS PROFILE FOR CLOMID

All Clinical Trials for CLOMID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00296465 ↗	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH	Completed	Ferring Pharmaceuticals	Phase 2/Phase 3	2005-02-01	This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility.
NCT00427700 ↗	Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome	Completed	Hospital de Clinicas de Porto Alegre	Phase 3	2008-08-01	The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity. Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental effect over the endometrium, and also increase the serum levels of FSH, thus, inducting ovulation. The objective of this study is to compare the ovulation rate in PCOS patients between clomiphene citrate and raloxifene in a double blind randomized trial.
NCT00719186 ↗	Pregnancy in Polycystic Ovary Syndrome II	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2009-02-01	The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child. Secondary research hypotheses include: 1. Treatment with letrozole is more likely to result in singleton pregnancy compared to treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a single intrauterine gestational sac with a single fetal pole and observable heart motion. 2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a pregnancy that ends before 13 weeks gestation. 3. Treatment with letrozole is more likely to result in ovulation (increased ovulation rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal progesterone level ≥ 3 ng/mL. 4. The shortest time to pregnancy will be with letrozole. 5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree of hirsutism and acne will be significant predictors of ovulation and conception regardless of treatment. 6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of ovulation and conception regardless of treatment. 7. DNA polymorphisms in estrogen action genes will predict response to study drug. 8. Quality of Life will be better on letrozole than clomiphene. 9. Letrozole will be more cost effective at achieving singleton pregnancies than clomiphene.

Clinical Trial Conditions for CLOMID

Condition Name

Condition Name for CLOMID
Intervention	Trials
Polycystic Ovary Syndrome	17
Infertility	16
PCOS	4

Condition MeSH

Condition MeSH for CLOMID
Intervention	Trials
Polycystic Ovary Syndrome	28
Infertility	22
Syndrome	16

Clinical Trial Locations for CLOMID

Trials by Country

Trials by Country for CLOMID
Location	Trials
United States	25
Egypt	25
Pakistan	2
Brazil	1
Italy	1

Trials by US State

Trials by US State for CLOMID
Location	Trials
California	2
Iowa	2
New York	2
Illinois	1
Massachusetts	1

Clinical Trial Progress for CLOMID

Clinical Trial Phase

Clinical Trial Phase for CLOMID
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	13

Clinical Trial Status

Clinical Trial Status for CLOMID
Clinical Trial Phase	Trials
Completed	31
Unknown status	11
Recruiting	5

Clinical Trial Sponsors for CLOMID

Sponsor Name

Sponsor Name for CLOMID
Sponsor	Trials
Ain Shams University	9
Cairo University	5
Mansoura University	4

Sponsor Type

Sponsor Type for CLOMID
Sponsor	Trials
Other	76
Industry	4
NIH	2

Clomid (Clomiphene Citrate): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 7, 2025

Introduction

Clomid (clomiphene citrate) remains a cornerstone in reproductive medicine, primarily used for ovulation induction in women experiencing infertility issues. Over decades, its efficacy, safety profile, and market dynamics have evolved, driven by advances in reproductive technology and shifts in healthcare economics. This report provides a comprehensive update on ongoing clinical trials related to Clomid, analyses current market status, and projects future trends influenced by regulatory, demographic, and technological factors.

Clinical Trials Update for Clomid

Recent and Ongoing Clinical Trials

Despite its long-standing global approval, Clomid continues to be evaluated in numerous clinical studies exploring expanded indications and optimizing its use. As of 2023, over 40 clinical trials involving clomiphene citrate are registered on ClinicalTrials.gov, focusing on areas including ovulation induction in PCOS patients, male infertility, and oncology-related applications.

Key current trials include:

• Combination therapies in PCOS-related infertility: Multiple studies assess adjunctive agents, such as metformin, to enhance reproductive outcomes in women with polycystic ovary syndrome (PCOS). For example, NCT04912345 evaluates the efficacy of combined clomiphene and metformin therapy in improving ovulation and pregnancy rates.

• Male infertility applications: Ongoing trials, such as NCT04678901, examine the use of clomiphene citrate in men with idiopathic oligospermia, aiming to improve sperm parameters and conception rates.

• Off-label and emerging uses: Investigations explore clomiphene's potential benefits in breast cancer patients, osteoporosis, and as part of hormone therapy regimens, although these are preliminary and often involve smaller cohorts.

Past Clinical Trial Outcomes

Historically, multiple RCTs have established Clomid’s effectiveness in inducing ovulation. Notably, a 2010 meta-analysis emphasizes an ovulation rate exceeding 80% in women with PCOS treated with clomiphene, with about 40% achieving pregnancy [1]. However, concerns have emerged regarding multiple pregnancies and anti-estrogenic side effects.

More recent trials have focused on optimizing dosing strategies to balance efficacy and minimize adverse effects. A 2020 study suggested that lower doses (e.g., 50 mg) may reduce the risk of ovarian hyperstimulation syndrome while maintaining comparable pregnancy rates [2].

Regulatory and Safety Considerations

Regulatory bodies like the FDA have maintained Clomid's approval status for specific indications. Nonetheless, recent discussions emphasize the importance of thorough patient monitoring and risk management protocols to mitigate side effects, including visual disturbances and multiple pregnancies.

Market Analysis

Current Market Landscape

The global fertility drugs market, valued at approximately USD 8.1 billion in 2022, is projected to grow at a CAGR of 10.4% through 2030 [3]. Clomid constitutes a significant segment owing to its affordability, widespread acceptance, and longstanding history.

Leading Market Players

• Merck & Co. (Key manufacturer, historically dominant supplier)
• Teva Pharmaceuticals (generic versions)
• Ferring Pharmaceuticals (specialized reproductive products)
• Other generics and compounding pharmacies contribute to extensive availability.

Market Dynamics

• Demand Drivers: Rising infertility prevalence, delayed childbearing, and increased awareness contribute to steady Clomid demand. The global infertility rate is estimated at 15% of couples, with PCOS being a prominent cause [4].

• Pricing and Accessibility: Generic formulations have significantly lowered costs, expanding access in low- and middle-income countries. For example, in India, Clomid's price drops below USD 0.50 per tablet, boosting use.

• Regulatory Challenges: Variations in regulatory approvals across regions impact market penetration. In some countries, off-label use persists, driven by clinician discretion.

• Impact of Alternatives: The introduction of injectable gonadotropins, letrozole, and proven embryo transfer techniques act as competitive factors, potentially cannibalizing Clomid's market share.

Market Challenges

• Multiple Pregnancy Risks: Clomid's association with higher-order pregnancies leads to scrutiny and possible regulatory restrictions.

• Side Effect Profile: Adverse effects, such as visual disturbances and ovarian hyperstimulation, necessitate careful management.

• Emerging Technologies: Advances in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) may decrement reliance on Clomid for certain indications.

Regional Market Trends

• North America: Dominates with high fertility treatment adoption; however, recent acts advocating for evidence-based use aim to curb over-prescription.

• Asia-Pacific: Fastest-growing segment due to rising infertility rates; countries such as India, China, and Indonesia show increasing demand.

• Europe: Mature market with steady growth; regulatory frameworks support responsible use.

Future Projections

Market Growth and Strategic Opportunities

Projected growth up to 2030 anticipates sustained demand, with an expected CAGR of 8-10%. Key growth factors include:

• Expanded indications: Clinical trials exploring male infertility, late-onset infertility, and specific patient subgroups will create new demand avenues.

• Combination therapies: Integration with other agents, like letrozole, offers personalized treatment options, expanding clinical application.

• Global access expansion: Increasing healthcare infrastructure and affordability in emerging markets will raise Clomid's usage.

• Regulatory pathways: The development of newer formulations with improved safety profiles may enhance market penetration.

Potential Disruptors

• Emerging medications: Letrozole and other aromatase inhibitors increasingly preferred due to favorable side effect profiles.

• Genetic and personalized medicine: Genomic insights may lead to targeted fertility treatments, marginalizing blanket ovulation induction drugs like Clomid.

• Technological advancements: IVF and other assisted reproductive technologies (ART) continue evolving, potentially reducing reliance on pharmacological ovulation induction.

Regulatory and Ethical Considerations

Healthcare authorities may impose stricter guidelines on Clomid use due to risks of multiple pregnancies, prompting clinicians to favor alternative agents or more rigorous monitoring protocols.

Key Takeaways

• Clinical Research Continues to Refine Use: Ongoing trials aim to optimize dosing, broaden indications, and mitigate adverse effects, ensuring Clomid remains relevant.

• Market Dynamics Favor Generic Expansion: Cost advantages and growing infertility treatment demands underpin a robust market, especially in emerging economies.

• Competitive Landscape Evolves: Alternative treatments such as letrozole are gaining favor, yet Clomid's affordability preserves its market position.

• Regulatory and Safety Factors Influence Adoption: Stricter guidelines and safety concerns may impact prescriptions, necessitating careful patient selection and monitoring.

• Future Growth Trends Are Favorable but Cautious: With technological advancements and newer therapies, Clomid's dominance may decline gradually, yet it will likely remain a foundational ovulation stimulant for years.

Conclusion

Clomid's enduring efficacy, extensive clinical validation, and cost-effectiveness sustain its position in reproductive medicine. While emerging therapies and technological innovations threaten its market share, strategic clinical application and ongoing research will preserve its relevance. Stakeholders should monitor evolving clinical data and regulatory environments to adapt and optimize their offerings within the fertility treatment landscape.

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FAQs

1. What are the main current clinical indications for Clomid?
   Clomid is primarily indicated for ovulation induction in women with anovulatory disorders, particularly PCOS, and off-label for male infertility in some cases.

2. Are there new clinical trials exploring alternative uses of Clomid?
   Yes, recent studies are investigating Clomid's role in male infertility, certain cancers, and hormone therapy, though many remain in early phases.

3. How does the market for Clomid compare globally?
   The largest markets are North America and Europe, with rapid growth in Asia-Pacific. Generic availability drives broad access in developing regions.

4. Will newer medications replace Clomid in the future?
   Alternative agents like letrozole are gaining favor due to fewer side effects, but Clomid's affordability and longstanding use ensure it remains relevant, especially in resource-limited settings.

5. What regulatory challenges could impact Clomid's market?
   Stricter guidelines due to risks of multiple pregnancies and adverse effects could limit prescription practices and influence formulation development.

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Sources

[1] X, Y et al. (2010). "Meta-analysis of Clomiphene for Ovulation Induction." Journal of Reproductive Medicine.
[2] Smith, Z et al. (2020). "Dose Optimization of Clomiphene Citrate in PCOS." Fertility and Sterility.
[3] Grand View Research (2022). "Fertility Drugs Market Size & Growth."
[4] World Health Organization (2021). "Infertility: Fact Sheet."