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Last update 08 May 2025

Secondary amenorrhea

Last update 08 May 2025

Basic Info

Synonyms

Loss of menstrual period, Periods have stopped, Secondary amenorrhea

+ [11]

Introduction-

Drugs associated with Secondary amenorrhea

Norethindrone Acetate

Target

Mechanism

PR agonists

Active Org.-

Originator Org.

Teva Branded Pharmaceutical Products R&D, Inc.

Active Indication-

Inactive Indication

Abnormal uterine bleeding [+3]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date21 Apr 1982

Progesterone

Target

Mechanism

PR modulators

Active Org.

Fresenius Kabi Austria GmbH [+22]

Originator Org.

Mochida Pharmaceutical Co., Ltd. [+1]

Active Indication

Endometrial Hyperplasia [+17]

Inactive Indication

Abnormal uterine bleeding [+15]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

Japan

First Approval Date25 Jan 1956

DR-2021

Target-

Mechanism-

Active Org.-

Originator Org.

Teva Pharmaceutical Industries Ltd.

Active Indication-

Inactive Indication

Hemorrhage [+2]

Drug Highest PhasePending

First Approval Ctry. / Loc.-

First Approval Date20 Jan 1800

Clinical Trials associated with Secondary amenorrhea

CTR20244041

/ CompletedNot Applicable

评估受试制剂地屈孕酮片（规格：10 mg）与参比制剂达芙通®（规格：10 mg）在健康成年受试者餐后状态下的单中心、随机、开放、单剂量、四周期、两序列、完全重复交叉生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, four-cycle, two-sequence, fully repeated crossover bioequivalence study to evaluate the test preparation Dydrogesterone Tablets (strength: 10 mg) and the reference preparation Daphaston® (strength: 10 mg) in healthy adult subjects in the fed state

主要研究目的：研究餐后状态下单次口服受试制剂地屈孕酮片（规格：10 mg，持证商：河南泰丰生物科技有限公司）与参比制剂地屈孕酮片（达芙通®，规格：10 mg，持证商：Abbott B.V.）在健康成年女性受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂地屈孕酮片（规格：10 mg）和参比制剂地屈孕酮片（达芙通®，规格：10 mg）在健康成年女性受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, licensee: Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation Dydrogesterone Tablets (Duphaston®, Specification: 10 mg, licensee: Abbott B.V.) in healthy adult female subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. The secondary purpose of the study is to evaluate the safety of the test preparation Dydrogesterone Tablets (Specification: 10 mg) and the reference preparation Dydrogesterone Tablets (Duphaston®, Specification: 10 mg) in healthy adult female subjects.

Start Date10 Nov 2024

Sponsor / Collaborator

Henan Taifeng Biotechnology Co., Ltd.

CTR20242976

/ CompletedNot Applicable

中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验

[Translation] A randomized, open-label, two-sequence, four-period repeated crossover bioequivalence study of oral dydrogesterone tablets in Chinese healthy female subjects in the fasting and fed state

（1）主要研究目的研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10mg，湖南醇健制药科技有限公司生产）与参比制剂地屈孕酮片（商品名：达芙通®，规格：10mg，Abbott Biologicals B.V.生产）在中国健康女性受试者体内的药代动力学，评价两制剂生物等效性。（2）次要研究目的评价中国健康女性受试者空腹和餐后单次口服受试制剂（T）地屈孕酮片和参比制剂（R）地屈孕酮片（达芙通®）后的安全性。

[Translation]

(1) Main study objectives To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (specification: 10 mg, produced by Hunan Chunjian Pharmaceutical Technology Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Daphaston®, specification: 10 mg, produced by Abbott Biologicals B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations. (2) Secondary study objectives To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Daphaston®) after a single oral administration in healthy Chinese female subjects after a fasting and fed state.

Start Date18 Sep 2024

Sponsor / Collaborator

Hunan Sterol pharmaceutical Co., Ltd

CTR20242989

/ CompletedNot Applicable

中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验

本试验旨在研究健康受试者单次空腹和餐后口服Mankind Pharma Limited, India生产的地屈孕酮片（10 mg）的药代动力学特征；以Abbott Healthcare Products B.V.生产的地屈孕酮片（Duphaston®，10 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。次要目的：评估受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

This study aims to study the pharmacokinetic characteristics of a single fasting and postprandial oral dose of dydrogesterone tablets (10 mg) produced by Mankind Pharma Limited, India in healthy subjects; using dydrogesterone tablets (Duphaston®, 10 mg) produced by Abbott Healthcare Products B.V. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and evaluate the bioequivalence of the two preparations in humans. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.

Start Date29 Aug 2024

Sponsor / Collaborator

Shenzhen Foncoo Pharmaceutical Co. Ltd.

100 Clinical Results associated with Secondary amenorrhea

100 Translational Medicine associated with Secondary amenorrhea

0 Patents (Medical) associated with Secondary amenorrhea

1,905

Literatures (Medical) associated with Secondary amenorrhea

01 May 2025·The Nurse Practitioner

Evaluating primary amenorrhea in the primary care setting

Article

Author: Moore, Ginny ; Spero, Susannah ; Breiten, Kaitlyn H. ; Hopkins, Leslie

ABSTRACTPrimary amenorrhea is the absence of menarche by age 15 years. Though not as common as secondary amenorrhea, primary care providers must know how to assess primary amenorrhea. Evaluation includes a thorough health history, physical exam, lab evaluation, and, in some cases, imaging. Primary amenorrhea has three broad causes: genetic, hormonal, and anatomic.

01 Apr 2025·International Journal of Biological Macromolecules

Therapeutic strategies: Bioactive hydrogels oxidized sodium alginate/strontium/betamethasone for preventing intrauterine adhesion

Article

Author: Yang, Shenyu ; Zhao, Yamin ; Chang, Lei ; Guo, Ruixia ; Wu, Fengling ; Tong, Ningyao ; Han, Liping ; Qiu, Luojie ; Li, Siyu ; Chen, Mengyu ; Miao, Qiuju ; Zhou, Junying ; Chen, Cheng

Intrauterine adhesion (IUA) is an endometrial damage repair disorder that leads to menstrual loss, amenorrhea, and infertility in women; therefore, addressing this dilemma is a critical challenge. In this study, a multifunctional hydrogel, comprising oxidized sodium alginate (OSA), strontium carbonate (SrCO₃), and betamethasone 21-phosphate sodium (BSP), was formulated to facilitate angiogenesis, reduce fibrosis, and support tissue repair in the treatment of IUA. The composite hydrogels showed significant bioactivity on human endometrial stromal cells (HESCs) and human umbilical vein endothelial cells (HUVECs), promoting the injured HESCs repair, reversing the degree of fibrosis to a certain extent, and enhancing the proliferation and migration of HUVECs. These results were also verified in the IUA model of sexually mature female rats. Compared with the model group, the selection of the appropriate hydrogel significantly increased endometrial thickness (p < 0.01), the number of glands (p < 0.001), decreased the degree of fibrosis (p < 0.05), and Vimentin (p < 0.01), CK19 (p < 0.01), CD31 (p < 0.01), and Ki67 (p < 0.01) molecular expression increased remarkably. In summary, in situ injection of this multifunctional hydrogel into the uterine cavity not only serves as a physical barrier, isolating the damaged endometrium, but also gradually releases drugs as the hydrogel degrades. This multifunctional hydrogel promotes endometrial proliferation and angiogenesis while reducing fibrosis, and provides therapeutic strategies for patients with clinical IUA.

01 Mar 2025·Endocrine Practice

Clinical Characteristics, and Prevalence of Hepatic and Bone Mineral Density Abnormalities in Patients With Sheehan Syndrome: Data From a Tertiary Care Center

Article

Author: Patto, Shoiab Mohd ; Dutta, Pinaki ; Mir, Shahnawaz ; Baba, Mohammad Salem ; Bhat, Shabir Ahmad ; Lone, Suhail Shafi ; Bhat, Mohammad Hayat

OBJECTIVESheehan syndrome (SS), or postpartum pituitary necrosis, occurs due to reduced vascular supply to pituitary gland after postpartum hemorrhage, often linked to coagulation abnormalities, and pituitary antibodies. A smaller sella turcica volume is a risk factor for SS, consequent to compressive effects on the pituitary stalk. Hypopituitarism in SS increases the risk of metabolic liver and bone diseases. This study aimed to assess the clinical profile of SS, estimate sella turcica volume, and quantify liver fat and bone mineral density.METHODSThis case-control study recruited 50 patients with SS and an equal number of healthy controls.RESULTSThe mean age (52.14 ± 8.47 vs 51.20 ± 7.46 years, P = .55) and body mass index (23.33 ± 3.61 vs 23.46 ± 3.10 kg/m², P = .86) were similar between patients with SS and controls. Lactational failure occurred in 88%, and 96% had secondary amenorrhea. Overall, 94% of patients had growth hormone deficiency, 96% had hypogonadism, 96% had thyrotroph failure, and 92% had corticotroph failure. Sella turcica volume was lower in patients with SS than in controls (350.90 ± 109.05 mm³ vs 565.47 ± 85.15 mm³, P ≤ .01) but there was no correlation with age, body mass index, childbirth duration, insulin-like growth factor 1, or number of pituitary hormone deficiencies. The distribution of hepatic steatosis was mild in 4%, moderate in 8% and severe in 12%. The results indicate that 10% of patients had mild fibrosis, 4% had moderate fibrosis, and none had severe fibrosis. Osteopenia was present in 30% of patients and osteoporosis in 60% of patients.CONCLUSIONPatients with SS had a lower sella turcica volume than controls. Additionally, 90% of patients had osteoporosis or osteopenia, and many also had hepatic steatosis or fibrosis.

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Secondary amenorrhea

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