Delving into the Latest Updates on Dydrogesterone with Synapse

Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states, using the dydrogesterone tablets (trade name: Duphaston, specification: 10 mg) of Abbott B.V. as the reference preparation and the dydrogesterone tablets (10 mg) developed by Hubei Minkang Pharmaceutical Group Co., Ltd. as the test preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

Start Date08 May 2025

Sponsor / Collaborator

Hubei Minkang Pharmaceutical Group Co., Ltd.

PACTR202504881516590

/ SuspendedNot ApplicableIIT

Comparative Evaluation of the Efficacy, Safety and Tolerability of Oral Dydrogesterone and Micronised Vaginal Progesterone in Luteal Phase Support During Assisted Reproductive Treatment in Enugu South Eastern Nigeria.

Start Date14 Apr 2025

Sponsor / Collaborator-

NCT06952296

/ Not yet recruitingNot Applicable

Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain

The study is an observational, multicenter, prospective, single arm study to evaluate the efficacy of dydrogesterone in endometriosis-related pain (EAP).

Start Date01 Apr 2025

Sponsor / Collaborator

Abbott Laboratories

100 Clinical Results associated with Dydrogesterone

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100 Translational Medicine associated with Dydrogesterone

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100 Patents (Medical) associated with Dydrogesterone

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1,269

Literatures (Medical) associated with Dydrogesterone

01 Jul 2025·JOURNAL OF HAZARDOUS MATERIALS

Screening and risk assessment of priority organic micropollutants for control in reclaimed water in China

Article

Author: Wang, Zijian ; Meng, Qingling ; Wen, Zhao ; Sun, Kaicheng ; Xue, Honghai

Organic micropollutants (OMPs) in reclaimed water have been frequently detected over the past decades, posing significant risks to ecosystems and human health. Given the complexity of these pollutants and the differences in their risk and toxicity, current assessments remain incomplete. This study conducted a large-scale investigation of OMPs in reclaimed water across China and developed a comprehensive multi-criteria integrated scoring method based on OMP toxicity and exposure potential. This method aims to protect aquatic organisms and human health by screening and prioritizing OMPs in reclaimed water, classifying their priority levels, and creating a prioritized control list. The study quantified OMP exposure potential, environmental persistence, bioaccumulation, and impacts on ecology and human health. The survey detected 369 OMPs from 11 chemical classes, with 325 compounds passing pre-selection. According to the prioritization scheme, 29 OMPs were identified as high priority, 171 as medium priority, and 125 as low priority. The BPs and Other Industrial Chemicals categories had the highest average maximum concentrations, followed by HPCCs and PAEs. High-priority pollutants were dominated by PAHs and PCBs, each comprising 31.03 %. Medium- and low-priority groups were mainly composed of Pesticides. PAHs and PCBs showed higher risk quotients, indicating significant ecological risks, while PCB 126, BaP, and PFOA exhibited high toxicity and potential health risks. This study provides valuable information for controlling priority pollutants in Chinese reclaimed water and establishes a foundation for OMP risk management. Future research should intensify monitoring to ensure the safe and sustainable use of water resources.

01 Jun 2025·MATURITAS

Swedish physicians' knowledge of and prescribing practices for menopausal hormone therapy: A nationwide cross-sectional survey

Article

Author: Cruz, Natalia ; Iliadis, Stavros I ; Skalkidou, Alkistis ; Götze Eriksson, Rebecca ; Lindén Hirschberg, Angelica

OBJECTIVES:

To investigate current prescribing practices, knowledge levels and related disparities regarding menopausal hormone therapy (MHT) among physicians in Sweden.

STUDY DESIGN:

A 45-item web-based MHT-focused survey conducted February-September 2023. Participants were specialists/residents in obstetrics and gynecology (gynaecologists) and general practitioners (GPs) in Sweden.

MAIN OUTCOME MEASURES:

Experience with MHT prescription, prescription patterns and challenges and perceived knowledge of and adherence to national guidelines among gynaecologists and GPs, analyzed quantitatively, along with potential differences between the two groups.

RESULTS:

In total, 542 physicians answered the survey (67.9 % gynaecologists and 32.1 % GPs). Over 90 % reported meeting women with menopausal symptoms in their clinical practice and among those 94.6 % prescribed systemic MHT. GPs prescribed MHT to a significantly lesser extent than gynaecologists. GPs reported a significantly higher level of difficulty in all but one of the examined aspects of MHT prescription. GPs demonstrated significantly lower awareness of current national guidelines than gynaecologists. Regarding self-perceived assessment of MHT-related education, 47.8 % of GPs, compared with 30.6 % of gynaecologists, reported inadequate theoretical education (p < 0.001). Physicians working in metropolitan areas were more experienced in prescribing micronized progesterone and dydrogesterone.

CONCLUSIONS:

Differences were observed between responding gynaecologists and GPs in MHT-related practices and knowledge. While GPs reported lower awareness of guidelines and encountered more challenges in prescribing MHT, nearly one-third of gynaecologists also indicated inadequate education in MHT. This study underscores the need for improved guideline awareness and accessible education to support evidence-based menopause care for the expanding midlife female population.

01 May 2025·Health Science Reports

Unraveling the Genetic and Environmental Risk Factors of Autism Spectrum Disorder Through a Case‐Control Study in Armenia

Article

Author: Harutyunyan, Hayk ; Yeritsyan, Hermine ; Yenkoyan, Konstantin ; Mkhitaryan, Meri ; Avetisyan, Tamara

ABSTRACT:

Background and Aims:

Autism spectrum disorder (ASD) is influenced by genetic and environmental factors. This study investigates genetic mutations and prenatal factors associated with ASD, including their interplay, in a multicenter case‐control study.

Methods:

The study included 297 participants (149 ASD cases, 148 controls). Genetic data were analyzed using Multiplex Ligation‐dependent Probe Amplification (MLPA) for ASD‐associated chromosomal regions. Environmental data covered prenatal, perinatal, and neonatal factors. Logistic regression and stratified analyses were performed.

Results:

Significant associations were found between ASD and mutations in 15q11−15q13, 16p11, and 11q13 regions, particularly in SHANK2 and SHANK3. Females with ASD showed higher mutation rates than males. Prenatal factors (e.g., MgB6 use, labor‐inducing drugs, maternal stress, pregnancy complications, shorter interpregnancy intervals) exacerbated ASD risk when combined with specific genetic variations. Duphaston use during pregnancy, alongside certain mutations, may influence ASD risk, potentially offering protective effects.

Conclusion:

This study highlights the importance of integrating genetic and environmental factors in ASD research. Findings underscore the need for tailored early interventions, prenatal care advice, and genetic counseling for at‐risk families. Future studies should validate these findings in larger, diverse populations and explore underlying mechanisms.

14

News (Medical) associated with Dydrogesterone

29 Nov 2024

·pharma.economictimes.indiatimes.com

CORONA’s manufacturing plant for hormonal products completed, production to begin by 2026

Ahmedabad: The construction of CORONA Remedies Private Limited, state-of-the-art hormonal product manufacturing plant in Bhayla, Ahmedabad has been completed and the company is expecting commercial production from the unit to commence in FY 2026. With an annual production capacity of 20 crore units, the plant is designed to meet growing domestic and international demand. It will focus on producing a range of female hormone products , including treatments for conditions such as dysmenorrhoea, polycystic ovary syndrome ( PCOS ), infertility, PMS & hormonal disorders . The facility is equipped with isolator systems for handling potent hormonal APIs , ensuring zero contamination, maximum safety and meets the highest regulatory standards. Nirav Mehta, Managing Director & CEO of CORONA Remedies said, “India’s women’s healthcare sector is growing rapidly, driven by increasing awareness and prevalence of conditions like PCOS infertility, PMS & hormonal disorders. With cutting-edge technology and adherence to global standards, we are poised to meet both local and global demand.” As per the release, “The company currently occupies four per cent market share in the female hormone category and leads in categories like progesterone, dydrogesterone, and norethisterone.” By Online Bureau ,

28 Nov 2024

·www.pharmaindustrial-india.com

CORONA Remedies to Launch its New Hormonal Products Manufacturing Plant in Ahmedabad

CORONA Remedies has announced about its upcoming state-of-the-art hormonal product manufacturing plant in Bhayla, Ahmedabad. The construction of the facility has been completed. Commercial production is expected to commence in FY 2026, marking a significant step forward in CORONA’s commitment to women’s healthcare. The new facility will focus on producing a range of essential female hormone products, including treatments for conditions such as dysmenorrhoea, polycystic ovary syndrome (PCOS), infertility, PMS & hormonal disorders. With an annual production capacity of 20 crore units, the plant is designed to meet growing domestic and international demand. CORONA Remedies already holds a strong position in the women’s health segment, with a 4 percent market share in the female hormone category. The company ranks among the top 10 players in the Indian market, with leadership in key products such as progesterone, dydrogesterone, and norethisterone. The company’s existing manufacturing infrastructure, certified by WHO-GMP and EU-GMP, supports its extensive portfolio in areas including cardiovascular care, neuropathy, pain management and urology. Two DSIR-approved R&D centres, staffed by over 100 scientists working on more than 80 projects, drive CORONA’s innovation. This new hormone facility will integrate advanced automation and AI technologies, reinforcing the company’s dedication to quality, safety, and efficacy. Nirav Mehta, Managing Director & CEO of CORONA Remedies, emphasised, “India’s women’s healthcare sector is growing rapidly, driven by increasing awareness and prevalence of conditions like PCOS infertility, PMS & hormonal disorders. Despite women comprising nearly 50 percent of the population, the country has very few specialised hormonal products’ manufacturing units. Our new facility aims to bridge this gap, ensuring high-quality, consistent hormonal products for millions of women. With cutting-edge technology and adherence to global standards, we are poised to meet both local and global demand.” The facility is equipped with advanced isolator systems for handling potent hormonal APIs, ensuring zero contamination and maximum safety. Designed to meet the highest regulatory standards, it reflects CORONA Remedies’ commitment to providing innovative and affordable healthcare solutions, reinforcing its position as a leader in India’s pharmaceutical industry.

28 Nov 2024

·www.pharmaindustrial-india.com

CORONA Remedies to Launch its New Hormonal Products Manufacturing Plant in Ahmedabad

CORONA Remedies has announced about its upcoming state-of-the-art hormonal product manufacturing plant in Bhayla, Ahmedabad. The construction of the facility has been completed. Commercial production is expected to commence in FY 2026, marking a significant step forward in CORONA’s commitment to women’s healthcare. The new facility will focus on producing a range of essential female hormone products, including treatments for conditions such as dysmenorrhoea, polycystic ovary syndrome (PCOS), infertility, PMS & hormonal disorders. With an annual production capacity of 20 crore units, the plant is designed to meet growing domestic and international demand. CORONA Remedies already holds a strong position in the women’s health segment, with a 4 percent market share in the female hormone category. The company ranks among the top 10 players in the Indian market, with leadership in key products such as progesterone, dydrogesterone, and norethisterone. The company’s existing manufacturing infrastructure, certified by WHO-GMP and EU-GMP, supports its extensive portfolio in areas including cardiovascular care, neuropathy, pain management and urology. Two DSIR-approved R&D centres, staffed by over 100 scientists working on more than 80 projects, drive CORONA’s innovation. This new hormone facility will integrate advanced automation and AI technologies, reinforcing the company’s dedication to quality, safety, and efficacy. Nirav Mehta, Managing Director & CEO of CORONA Remedies, emphasised, “India’s women’s healthcare sector is growing rapidly, driven by increasing awareness and prevalence of conditions like PCOS infertility, PMS & hormonal disorders. Despite women comprising nearly 50 percent of the population, the country has very few specialised hormonal products’ manufacturing units. Our new facility aims to bridge this gap, ensuring high-quality, consistent hormonal products for millions of women. With cutting-edge technology and adherence to global standards, we are poised to meet both local and global demand.” The facility is equipped with advanced isolator systems for handling potent hormonal APIs, ensuring zero contamination and maximum safety. Designed to meet the highest regulatory standards, it reflects CORONA Remedies’ commitment to providing innovative and affordable healthcare solutions, reinforcing its position as a leader in India’s pharmaceutical industry.

100 Deals associated with Dydrogesterone

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External Link

KEGG	Wiki	ATC	Drug Bank
D01217	Dydrogesterone	G03DB01	DB00378

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Uterine Hemorrhage	China	Abbott Healthcare Products BV	31 Dec 2002
Abortion, Habitual	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Abortion, Threatened	Japan	Viatris Healthcare GK	31 Oct 1964
Amenorrhea	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Dysmenorrhea	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Infertility	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Metrorrhagia	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Endometriosis	United Kingdom	Solvay SA	01 Jan 1961
Menstruation Disturbances	United Kingdom	Solvay SA	01 Jan 1961

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 3	Austria	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Belgium	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Finland	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Germany	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Israel	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Russia	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Spain	Abbott Laboratories	01 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03858049 (CTgov)	Phase 4	Infertility	172	Crinone	bkviazhdhh = tuwaphognd afzhnzsiqw (agavoubnym, kuljgmtmus - morkvhyicg) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Combined Oral Contraceptive+Decapeptyl+Cyclo-Progynova+progesterone+Gonadotropin+Duphaston (the Progestin Primed Double Stimulation Group)	zavyrbnlty(kvvmnyklaw) = hodninraes qwialkmako (iiljmfpwhm, uixqmbzjrt - iyhljbilsw) View more	-	17 Feb 2022
				Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist)	nlgpdexggm(pgdlfyvwcl) = xwfpganbaf scmugneqyi (jsqbclmlzy, wgbdpqrlos - tpkfzwyxii) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	ppifzeteoj(rgkbdnfjud) = llshspjeod iaikkdadey (wkwwtilkvy )	Negative	28 Jan 2021
				Placebo	ppifzeteoj(rgkbdnfjud) = tizidehvvi iaikkdadey (wkwwtilkvy )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	dkuyxqfnum = zginevxxms yiebxxnwrr (hxxszylyqh, fmyxhryqvm - evqrgdwydl) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	dkuyxqfnum = ugaghrhhph yiebxxnwrr (hxxszylyqh, jqohottduv - pfllaejbgy) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	umoazisfqa(xlyatcxoov) = hccjlmmlbq qthbrdrsyt (teydtfonaz ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	umoazisfqa(xlyatcxoov) = hcllcesujl qthbrdrsyt (teydtfonaz ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	xjnlhgrgaq = raelrxqyhu tgojxbntqf (uyqbjjobna, iopqjwjsow - vgvyaeedxa) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	xjnlhgrgaq = lbiuimbtca tgojxbntqf (uyqbjjobna, mnyepztljl - rhnzhtziic) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	wuhyryyspw(gwoshocyrh) = ogsgnqvemh mpcwaymydm (oqrrkdxfpe ) View more	-	01 Sep 2017
				Utrogestan	wuhyryyspw(gwoshocyrh) = ovwaxkwvdd mpcwaymydm (oqrrkdxfpe ) View more
NCT01850030 (Lotus I, Pubmed \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	dnrfwyajkt(dpwllnaltr) = pgudwttuxi vzieymgkqb (rgcuyxnqnn ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	dnrfwyajkt(dpwllnaltr) = lcllylultv vzieymgkqb (rgcuyxnqnn ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	pxlrasysmp(wcosslhulc) = hclkwfgflt bpdnicmqzl (rwlzidisyd ) View more	Negative	09 Feb 2016
				Oral placebo	pxlrasysmp(wcosslhulc) = ljcullmovn bpdnicmqzl (rwlzidisyd ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	dvyvjhzpkd(fyqnocmepp) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group neldijitzy (dxrxiwlqaq ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston