本试验旨在研究单次空腹和餐后口服浙江仙琚制药股份有限公司研制、生产的炔雌醇环丙孕酮片（炔雌醇0.035 mg + 醋酸环丙孕酮2 mg）的药代动力学特征；以Bayer Weimar GmbH und Co. KG生产的炔雌醇环丙孕酮片（达英-35®，炔雌醇0.035 mg + 醋酸环丙孕酮2 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral administration of ethinyl estradiol cyproterone acetate tablets (0.035 mg ethinyl estradiol + 2 mg cyproterone acetate) developed and produced by Zhejiang Xianjun Pharmaceutical Co., Ltd.; using ethinyl estradiol cyproterone acetate tablets (Diane-35®, 0.035 mg ethinyl estradiol + 2 mg cyproterone acetate) produced by Bayer Weimar GmbH und Co. KG as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

Start Date26 Feb 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Co., Ltd.

NCT05657171 / CompletedNot ApplicableIIT

"Effect of Cyproterone Acetate / Ethinyl Estradiol Combination on Periodontal Tissue and High Sensitivity C- Reactive Protein Levels in Women With Polycystic Ovary Syndrome Having Gingivitis."

PCOS is a widely reported condition among young female population and anti-androgen agents are increasingly being used as part of the medical management of such cases. However, Clinical studies have reported higher prevalence of gingival inflammation, loss of attachment and gingival enlargement in women taking hormone based oral contraceptives. Additionally, CPA has been reported to have an osteoclastic action. Therefore, it is necessary to explore the effects of these medications on the periodontal condition of PCOS patients having gingivitis, who already are pre-disposed to systemic inflammation. Therefore, the present study aims to longitudinally evaluate the effect of CPA/EE combination regimen on the periodontal status of female patients diagnosed with PCOS with pre-existing gingivitis..

Start Date12 Dec 2022

Sponsor / Collaborator

Postgraduate Institute of Dental Sciences Rohtak

NCT05316935 / RecruitingPhase 2/3IIT

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

Start Date13 Jul 2022

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Cyproterone Acetate/Ethinylestradiol

100 Translational Medicine associated with Cyproterone Acetate/Ethinylestradiol

100 Patents (Medical) associated with Cyproterone Acetate/Ethinylestradiol

161

Literatures (Medical) associated with Cyproterone Acetate/Ethinylestradiol

31 Dec 2024·Gynecological Endocrinology

Comparative effects of the antioxidant glutathione with metformin and Diane-35 on hormonal, metabolic, and inflammatory indicators in a DHEA-induced PCOS rat model

Article

Author: Timur, Hikmet Tunç ; Tanoglu, Fatma Basak ; Özkara, Gülçin ; Tok, Olgu Enis ; Çetin, Çağlar ; Coşar, Aslı ; Neccar, Duygu ; Özcan, Pınar

OBJECTIVEComparison of hormonal, metabolic and inflammatory markers of glutathione with metformin and Diane-35 in a rat model of PCOS induced by dehydroepiandrosterone.METHODSTwenty-five female rats were randomized into four groups. Group 1 was administered a subcutaneous dose of 0.2 ml saline/day. Group 2 was given 0.2 ml of 1% carboxymethyl cellulose (CMC)/day orally for 28 days. A PCOS model was established with DHEA in rats. Group 3 was given 4.5 mg/kg/day of Diane-35 orally dissolved in 1% CMC for 28 days. Group 4 was given 300 mg/kg/day of metformin orally dissolved in 1 ml of saline for 28 days, and Group 5 was administered 100 mg/kg of glutathione intraperitoneally on days 35, 42, and 49. On day 56, the rats were sacrificed. Serum markers and follicle count were examined.RESULTSSerum IL-6, hs-CRP, insulin, testosterone, SHBG, and MDA values were significantly lower in the glutathione group than in the PCOS group (p = 0.0006, p = 0.023, p = 0.0082, p = 0.0007, p = 0.0048, and p < 0.0001, respectively).The number of all follicles was similar between the control and glutathione groups (p < 0.05). When we compared the other groups with the PCOS group, the number of primary, secondary, atretic, and cystic follicles was significantly lower in the metformin and glutathione groups. The number of primordial and antral follicles was significantly higher than in the PCOS group.CONCLUSIONSGlutathione plays anti-inflammatory and antioxidant roles, similar to metformin, by lowering serum IL-6, insulin, testosterone, CRP, and MDA levels; decreasing atretic/cystic follicle count; and improving antral follicle count and folliculogenesis in PCOS patients.

01 Sep 2024·Heliyon

Efficacy and safety of cangfu daotan decoction as an adjuvant treatment of Diane-35 for polycystic ovary syndrome: A systematic review and meta-analysis

Article

Author: Xu, Sheng ; Cheng, Shaomin ; Feng, Xianjie ; Chen, Xin ; Zhou, Xu

ObjectiveCangfu Daotan decoction is a classic traditional Chinese medicine formula that has been found to be beneficial for treating polycystic ovarian syndrome (PCOS) in animal models. This systematic review aimed to assess the efficacy and safety of Cangfu Daotan decoction as an adjuvant treatment to Diane-35 for PCOS in humans.MethodsSeven electronic databases were searched up to June 22, 2024, to identify randomized controlled trials (RCTs) that evaluated Cangfu Daotan decoction combined with Diane-35 versus Diane-35 alone for the treatment of PCOS. The effects of individual RCTs were combined via meta-analysis and were measured as relative risks (RRs) or weighted mean differences (WMDs).ResultsTwenty-five RCTs with a moderate to high risk of bias were included, involving 1845 patients with PCOS. Meta-analyses indicated that compared with Diane-35 alone, the combination of Diane-35 and Cangfu Daotan decoction significantly improved the response rate (RR 1.19, 95 % confidence interval [CI] 1.14 to 1.24), pregnancy rate (RR 1.57, 95 % CI 1.18 to 2.09), ovulation rate (RR 1.22, 95 % CI 1.11 to 1.35), and ovarian volume (WMD -1.43 cm³, 95 % CI -2.46 to -0.39). Cangfu Daotan decoction also significantly reduced the luteinizing hormone (LH) level, LH:FSH ratio, testosterone level, prolactin level, body mass index (BMI) and hirsutism and acne scores but had no significant effect on the follicle-stimulating hormone (FSH) level. All adverse events were mild and not related to Cangfu Daotan decoction treatment.ConclusionsThe findings suggest that Cangfu Daotan decoction, as an adjuvant therapy to Diane-35 for the treatment of PCOS, can reduce multiple sex hormone levels and BMI, relieve hyperandrogenism signs, and ultimately improve pregnancy outcomes, with good safety. The effect of Cangfu Daotan decoction on FSH remains uncertain. Due to limitations of risk of bias and heterogeneity, the quality of evidence was rated as moderate to very low.

01 Feb 2024·Skin Research and Technology

Observing the clinical efficacy of combined serum microneedle therapy for moderate to severe androgenetic alopecia in scalp repair

Article

Author: Zhang, Fan ; Jin, Qiuzi ; Jia, Shutong ; Li, Man ; Li, Fenfen ; Ye, Bo ; Zhang, Jiayu

AbstractObjectiveIn this study, the safety and efficacy of scalp repair serum microneedles combined with oral drug administration and topical medication were investigated for the treatment of moderate to severe androgenetic alopecia.MethodsTwenty patients, consisting of 4 males and 16 females, who sought treatment for moderate to severe androgenetic alopecia at our hair medicine research center alopecia specialty clinic between August and December 2022 were randomly selected for the study. Male patients underwent oral administration of finasteride topical application of 5% minoxidil, and biweekly scalp repair serum microneedle therapy. Female patients were administered spironolactone or Diane‐35 orally and applied 2% minoxidil topically, paired with biweekly scalp repair serum microneedle therapy sessions. After seven treatments, the scalp repair serum microneedle was discontinued, but oral administration and topical applications were continued, followed by a 1‐month follow‐up. Using a hair dermoscopy, hair follicles in a fixed region on the top of the head were manually counted per unit area to evaluate the hair restoration status of the patients quantitatively.ResultsAll 20 patients completed 3 months of combined therapy and a 1‐month follow‐up. On average, the patients experienced an increase of 42.6 hairs, with an efficiency rate of 100%. Significant differences were observed in hair count between any two of the first seven treatments (p < 0.001). A significant negative correlation was discovered between the initial pre‐treatment hair count and the total improvement of hair (p < 0.001), indicating that the greater the degree of hair loss before treatment, the more pronounced the improvement.ConclusionScalp repair serum microneedle combined therapy in moderate to severe androgenetic alopecia significantly reduces the number of microneedle treatments required, enhances treatment efficacy, and improves therapeutic outcomes.

100 Deals associated with Cyproterone Acetate/Ethinylestradiol

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	CN	Bayer Vital GmbH	20 Aug 2004
Hirsutism	CN	Bayer Vital GmbH	20 Aug 2004
Prostatic Cancer	CN	Bayer Vital GmbH	20 Aug 2004
Puberty, Precocious	CN	Bayer Vital GmbH	20 Aug 2004

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04964193 (CTgov)	Not Applicable	-	24	Elzsa film-coated tablet (Elzsa Film-coated Tablet)	rnvilkmbeo(kwtjbriyew) = umwjhwkbxe sbczkkgpss (zwsvsqssvv, ufuiothynl - fakwxksevj) View more	-	31 Jan 2022
				Diane-35 Sugar-coated tablet (Diane-35 Sugar-coated Tablet)	rnvilkmbeo(kwtjbriyew) = fqvdojjflg sbczkkgpss (zwsvsqssvv, wegqyssxat - etjjsphxng) View more

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