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Last Updated: June 18, 2025

CLINICAL TRIALS PROFILE FOR SEROPHENE


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All Clinical Trials for Serophene

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00719186 ↗ Pregnancy in Polycystic Ovary Syndrome II Completed Penn State University 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.
NCT00719186 ↗ Pregnancy in Polycystic Ovary Syndrome II Completed The University of Texas Health Science Center at San Antonio 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.
NCT00719186 ↗ Pregnancy in Polycystic Ovary Syndrome II Completed University of Colorado, Denver 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.
NCT00719186 ↗ Pregnancy in Polycystic Ovary Syndrome II Completed University of Michigan 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.
NCT00719186 ↗ Pregnancy in Polycystic Ovary Syndrome II Completed University of Pennsylvania 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Serophene

Condition Name

Condition Name for Serophene
Intervention Trials
Hypogonadism 2
Hypoandrogenism 1
Male Infertility 1
Non Obstructive Azoospermia 1
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Condition MeSH

Condition MeSH for Serophene
Intervention Trials
Hypogonadism 3
Infertility 2
Infertility, Male 1
Myofibroma 1
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Clinical Trial Locations for Serophene

Trials by Country

Trials by Country for Serophene
Location Trials
United States 12
Spain 1
Switzerland 1
Brazil 1
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Trials by US State

Trials by US State for Serophene
Location Trials
Maryland 1
New York 1
Virginia 1
Vermont 1
Texas 1
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Clinical Trial Progress for Serophene

Clinical Trial Phase

Clinical Trial Phase for Serophene
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Serophene
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Withdrawn 1
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Clinical Trial Sponsors for Serophene

Sponsor Name

Sponsor Name for Serophene
Sponsor Trials
Yale University 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
University of Illinois at Chicago 2
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Sponsor Type

Sponsor Type for Serophene
Sponsor Trials
Other 16
NIH 2
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SEROPHENE (Clomiphene Citrate): Clinical Trials, Market Analysis, and Projections

Introduction to SEROPHENE

SEROPHENE, also known as clomiphene citrate, is a medication primarily used to treat ovulatory dysfunction in women who are trying to conceive. It works by stimulating the hypothalamus to release gonadotropin-releasing hormone, which in turn stimulates the pituitary gland to release follicle-stimulating hormone (FSH) and luteinizing hormone (LH), leading to ovarian stimulation and ovulation[1].

Clinical Trials and Efficacy

Ovulation and Pregnancy Rates

Clinical trials have shown that clomiphene citrate is highly effective in inducing ovulation and achieving pregnancy. In studies involving 8,228 patients with ovulatory dysfunction, an ovulatory response was observed in 74% of the patients, and successful therapy characterized by pregnancy occurred in approximately 31% of the patients[1][4].

Adverse Events and Safety

Clinical trials have also documented the adverse events associated with clomiphene citrate. Common side effects include hot flashes, dizziness, and visual disturbances. More serious adverse events, such as ovarian overstimulation, can occur, especially at higher doses. The incidence of multiple pregnancies, including twins, triplets, and higher-order multiples, is also a significant consideration[1][4].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on fertility treatments, including those involving clomiphene citrate. Patients undergoing fertility treatments, including clomiphene citrate, were advised to suspend treatment if they tested positive for COVID-19, according to guidelines from the American Society for Reproductive Medicine (ASRM)[2].

Market Analysis

Current Market Size and Growth

The clomiphene citrate market was valued at approximately $10.02 million in 2020 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.4% from 2020 to 2027, reaching an estimated value of $14.51 million by 2027[2].

Geographic Segmentation

The market is segmented geographically into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America and Europe are significant markets driven by high healthcare expenditure and advanced healthcare infrastructure. The Asia-Pacific region shows substantial growth potential due to its large population and improving healthcare facilities. Latin America and the Middle East & Africa also exhibit growth, though at a slower pace compared to North America and Europe[2][5].

Key Players

The clomiphene citrate market includes several key players such as Sanofi S.A., Par Pharmaceutical, Merck & Co. Inc., Teva Pharmaceutical Industries Ltd., Cipla Inc., Unichem Laboratories Ltd., and others. These companies play a crucial role in the production, distribution, and marketing of clomiphene citrate[2].

Market Projections

Forecast Period

The clomiphene citrate market is expected to continue its growth trajectory. By 2031, the market is projected to reach $1,780.04 million, growing at a CAGR of 5.4% from 2024 to 2031[5].

Growth Drivers

The growth of the clomiphene citrate market is driven by several factors, including an increasing prevalence of infertility, rising awareness about fertility treatments, and supportive healthcare policies. Additionally, advancements in healthcare infrastructure, particularly in the Asia-Pacific region, contribute to the market's expansion[2][5].

Challenges and Restraints

Despite the growth potential, the market faces challenges such as the impact of the COVID-19 pandemic on fertility treatments and the potential for adverse events associated with clomiphene citrate. The need for careful patient selection and monitoring to minimize risks is also a significant consideration[1][2].

Conclusion

SEROPHENE (clomiphene citrate) remains a vital medication in the treatment of ovulatory dysfunction and infertility. Its efficacy in clinical trials and its market growth projections indicate a continued demand for this drug. However, it is crucial to balance the benefits of treatment with the potential risks and to adhere to guidelines set by healthcare authorities.

Key Takeaways

  • Efficacy: Clomiphene citrate is effective in inducing ovulation and achieving pregnancy in women with ovulatory dysfunction.
  • Market Growth: The market is projected to grow at a CAGR of 5.4% from 2020 to 2027 and reach $1,780.04 million by 2031.
  • Geographic Segmentation: North America, Europe, and the Asia-Pacific region are key markets driven by different factors.
  • Challenges: The COVID-19 pandemic and potential adverse events are significant challenges.
  • Growth Drivers: Increasing prevalence of infertility, rising awareness, and supportive healthcare policies drive market growth.

FAQs

What is SEROPHENE (clomiphene citrate) used for?

SEROPHENE (clomiphene citrate) is used to treat ovulatory dysfunction in women who are trying to conceive.

What are the common side effects of clomiphene citrate?

Common side effects include hot flashes, dizziness, and visual disturbances. More serious adverse events can include ovarian overstimulation.

How effective is clomiphene citrate in inducing ovulation and pregnancy?

Clinical trials have shown that clomiphene citrate induces ovulation in approximately 74% of patients and results in pregnancy in about 31% of patients.

What is the projected market size of clomiphene citrate by 2031?

The market is projected to reach $1,780.04 million by 2031, growing at a CAGR of 5.4% from 2024 to 2031.

How has the COVID-19 pandemic affected the use of clomiphene citrate?

The COVID-19 pandemic has led to the suspension of fertility treatments, including clomiphene citrate, for patients who test positive for COVID-19, according to ASRM guidelines.

Sources

  1. Clomiphene Citrate Tablets, USP 50 mg - PRODUCT MONOGRAPH. hres.ca.
  2. Clomiphene Citrate Market Size, Trends And Forecast To 2027. Coherent Market Insights.
  3. Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]. Fortune Business Insights.
  4. Serophene: Package Insert / Prescribing Information. Drugs.com.
  5. Clomiphene Citrate Market Size, Share, Scope, Growth & Forecast. Verified Market Research.
Last updated: 2025-01-04

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