CLINICAL TRIALS PROFILE FOR DYDROGESTERONE

All Clinical Trials for dydrogesterone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01178931 ↗	Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support	Completed	University of Zagreb	N/A	2010-10-01	The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support. (Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)
NCT00956267 ↗	Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.	Completed	Mansoura University	N/A	2006-08-01	The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.
NCT00911313 ↗	Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome	Completed	Mansoura University	N/A	2006-06-01	The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.
NCT00251082 ↗	Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination	Completed	Solvay Pharmaceuticals	Phase 3	2005-12-01	To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year
NCT00145522 ↗	Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women	Completed	Solvay Pharmaceuticals	Phase 4	2005-11-01	This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.
NCT00160316 ↗	Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination	Completed	Solvay Pharmaceuticals	Phase 3	2005-04-01	The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.
NCT00193674 ↗	Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage	Completed	Abbott Products	Phase 3	2003-09-01	The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).

Clinical Trial Conditions for dydrogesterone

Condition Name

Condition Name for dydrogesterone
Intervention	Trials
Infertility	8
Infertility, Female	5
Dydrogesterone	3
Preterm Labor	3

Condition MeSH

Condition MeSH for dydrogesterone
Intervention	Trials
Infertility	16
Infertility, Female	7
Abortion, Spontaneous	6
Premature Birth	4

Clinical Trial Locations for dydrogesterone

Trials by Country

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Trials by Country for dydrogesterone
Location	Trials
Japan	13
China	9
Egypt	7
Thailand	6
Russian Federation	4

Clinical Trial Progress for dydrogesterone

Clinical Trial Phase

Clinical Trial Phase for dydrogesterone
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	11
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for dydrogesterone
Clinical Trial Phase	Trials
Completed	22
Not yet recruiting	11
Recruiting	10

Clinical Trial Sponsors for dydrogesterone

Sponsor Name

Sponsor Name for dydrogesterone
Sponsor	Trials
Solvay Pharmaceuticals	3
Mansoura University	3
CRG UZ Brussel	3

Sponsor Type

Sponsor Type for dydrogesterone
Sponsor	Trials
Other	68
Industry	12

Dydrogesterone: Clinical Trials, Market Analysis, and Projections

Introduction

Dydrogesterone, a synthetic progestin, has been gaining significant attention in the field of reproductive medicine, particularly for its use in luteal phase support (LPS) during assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and frozen-thawed embryo transfer (FET) cycles. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Luteal Phase Support in FET Cycles

Recent studies have highlighted the efficacy of dydrogesterone in LPS. A study comparing different progesterone regimens in HRT-FET cycles found that the use of oral dydrogesterone, either alone or in combination with micronized progesterone gel, resulted in higher clinical pregnancy rates and live birth rates compared to micronized progesterone gel alone[1].

Comparison with Micronized Vaginal Progesterone

A prospective randomized study compared 40 mg/day oral dydrogesterone with 800 mg/day micronized vaginal progesterone in FET cycles. The results showed similar reproductive outcomes, including biochemical pregnancy, clinical pregnancy, and live birth rates, indicating that oral dydrogesterone is a reasonable and patient-friendly option[3].

Large-Scale Trials

The LOTUS I and II studies, large-scale phase III randomized controlled trials, demonstrated that oral dydrogesterone is superior to or as effective as micronized progesterone capsules or vaginal gel in fresh IVF cycles. These studies underscore the high efficacy and good tolerability of dydrogesterone[1].

Safety Profile

A recent study provided reassurance regarding the safety of dydrogesterone, particularly in the first trimester. The analysis concluded that there is no additional risk of congenital anomalies associated with the use of dydrogesterone, offering clear reassurance to patients and healthcare providers[5].

Market Analysis

Current Market Size

As of 2023, the global dydrogesterone market was valued at approximately USD 595.5 million to USD 567.86 million, depending on the source[2][4].

Growth Projections

The market is expected to grow significantly, with a projected compound annual growth rate (CAGR) of 9.45% to 9.7% from 2024 to 2030. By 2030, the market is anticipated to reach USD 1,069 million to USD 1,147 million[2][4].

Regional Consumption

The Asia-Pacific region is the largest consumer of dydrogesterone, accounting for nearly 62.27% of the market share. This indicates a strong demand and potential for further growth in this region[4].

Market Segmentation

The dydrogesterone market can be segmented by product type, dosage strength, applications, distribution channels, end users, and packaging type. Key product types include oral tablets, injectable formulations, and suppositories. The market is also segmented by dosage strengths such as 5 mg, 10 mg, and 20 mg[2].

Key Players

Major players in the dydrogesterone market include Abbott and Viatris. These companies are driving innovation and expansion in the market through various strategies, including product development and distribution[4].

Patient Acceptance and Ease of Use

Oral dydrogesterone is often preferred by patients due to its ease of use and lower cost compared to other forms of progesterone. This patient-friendly aspect is expected to contribute to the growing demand for the drug[3].

Future Projections

Market Expansion

Given the strong CAGR and increasing demand, the dydrogesterone market is poised for significant expansion. The growing need for effective LPS options in ART cycles, coupled with the drug's safety and efficacy profile, will likely drive this growth.

Research and Development

Continued research and clinical trials will be crucial in further establishing the benefits and potential applications of dydrogesterone. Future studies may explore its use in other reproductive health contexts, potentially expanding its market reach.

"DYD has high oral bioavailability, high specificity for P4 receptors, and a good tolerability profile," highlighting its potential as a promising LPS option in FET cycles[1].

Key Takeaways

• Efficacy in LPS: Dydrogesterone has shown superior or comparable efficacy to other progesterone forms in clinical trials for LPS in FET cycles.
• Safety Profile: There is no additional risk of congenital anomalies associated with dydrogesterone use.
• Market Growth: The global dydrogesterone market is projected to grow at a CAGR of 9.45% to 9.7% from 2024 to 2030.
• Regional Dominance: The Asia-Pacific region is the largest consumer of dydrogesterone.
• Patient Preference: Oral dydrogesterone is preferred due to its ease of use and lower cost.

FAQs

What is the current market size of the dydrogesterone market?

The global dydrogesterone market was valued at approximately USD 595.5 million to USD 567.86 million in 2023[2][4].

What is the projected growth rate of the dydrogesterone market?

The market is expected to grow at a CAGR of 9.45% to 9.7% from 2024 to 2030[2][4].

Which region consumes the most dydrogesterone?

The Asia-Pacific region is the largest consumer, accounting for nearly 62.27% of the market share[4].

Is dydrogesterone safe during pregnancy?

Studies have shown that dydrogesterone does not increase the risk of congenital anomalies, providing reassurance for its use during pregnancy[5].

Why is oral dydrogesterone preferred by patients?

Oral dydrogesterone is preferred due to its ease of use and lower cost compared to other forms of progesterone[3].

Sources

1. Frontiers in Endocrinology: "Supplementary dydrogesterone is beneficial as luteal phase support in hormone replacement therapy-frozen-thawed embryo transfer cycles: a real-world study"[1].
2. 360iResearch: "Dydrogesterone Market Size & Share 2025-2030"[2].
3. Clinical and Experimental Obstetrics & Gynecology: "Randomized Clinical Trial Comparing Oral Dydrogesterone to Micronized Vaginal Progesterone in Frozen-Thawed Embryo Transfer Cycles"[3].
4. Valuates Reports: "Global Dydrogesterone Drug Market Research Report 2024"[4].
5. Human Reproduction Open: "No additional risk of congenital anomalies after first-trimester exposure to dydrogesterone: a systematic review and meta-analysis"[5].