estradiol and progesterone

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · FDA-approved active Small molecule

estradiol and progesterone is a Hormone replacement therapy (HRT) Small molecule drug developed by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. It is currently FDA-approved for Menopausal vasomotor symptoms (hot flashes, night sweats), Postmenopausal osteoporosis prevention, Genitourinary atrophy and related symptoms. Also known as: Estradiol Valerate, Progynova, corpus luteum hormone, luteal hormone.

Estradiol and progesterone are hormone replacement therapy agents that restore circulating levels of endogenous female sex hormones.

Estradiol and progesterone are small molecule hormones used in medical interventions for conditions such as fertility, contraception, ectopic pregnancy, osteoporosis, and IVF, as well as in hormone replacement therapy. They are involved in the regulation of cervical mucus secretion, as demonstrated by the completed clinical trial "Regulation of Cervical Mucus Secretion" (NCT02969590).

At a glance

Generic name	estradiol and progesterone
Also known as	Estradiol Valerate, Progynova, corpus luteum hormone, luteal hormone, 3,20-pregnene-4; 4-pregnene-3,20-dione
Sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Drug class	Hormone replacement therapy (HRT)
Target	Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR)
Modality	Small molecule
Therapeutic area	Endocrinology / Women's Health
Phase	FDA-approved

Mechanism of action

Estradiol is a potent estrogen that binds to estrogen receptors (ERα and ERβ) throughout the body, while progesterone binds to progesterone receptors. Together, they restore hormonal balance in postmenopausal or hypogonadal women, alleviating vasomotor symptoms and supporting bone health, cardiovascular function, and genitourinary health. The combination mimics the natural hormonal cycle more closely than estrogen monotherapy.

Approved indications

• Menopausal vasomotor symptoms (hot flashes, night sweats)
• Postmenopausal osteoporosis prevention
• Genitourinary atrophy and related symptoms

Common side effects

• Breast tenderness
• Vaginal bleeding or spotting
• Headache
• Nausea
• Increased risk of venous thromboembolism
• Increased risk of breast cancer (with prolonged use)

Key clinical trials

• Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea (PHASE3)
• Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
• Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency (PHASE3)
• Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients (NA)
• Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study
• A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) (PHASE2)
• Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer
• A Prospective Multicenter Observational Real-world Study of Retained Products of Conception

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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• estradiol and progesterone CI brief — competitive landscape report
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• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University portfolio CI

Frequently asked questions about estradiol and progesterone

What is estradiol and progesterone?

estradiol and progesterone is a Hormone replacement therapy (HRT) drug developed by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, indicated for Menopausal vasomotor symptoms (hot flashes, night sweats), Postmenopausal osteoporosis prevention, Genitourinary atrophy and related symptoms.

How does estradiol and progesterone work?

Estradiol and progesterone are hormone replacement therapy agents that restore circulating levels of endogenous female sex hormones.

What is estradiol and progesterone used for?

estradiol and progesterone is indicated for Menopausal vasomotor symptoms (hot flashes, night sweats), Postmenopausal osteoporosis prevention, Genitourinary atrophy and related symptoms.

Who makes estradiol and progesterone?

estradiol and progesterone is developed and marketed by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (see full Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University pipeline at /company/sun-yat-sen-memorial-hospital-of-sun-yat-sen-university).

Is estradiol and progesterone also known as anything else?

estradiol and progesterone is also known as Estradiol Valerate, Progynova, corpus luteum hormone, luteal hormone, 3,20-pregnene-4; 4-pregnene-3,20-dione.

What drug class is estradiol and progesterone in?

estradiol and progesterone belongs to the Hormone replacement therapy (HRT) class. See all Hormone replacement therapy (HRT) drugs at /class/hormone-replacement-therapy-hrt.

What development phase is estradiol and progesterone in?

estradiol and progesterone is FDA-approved (marketed).

What are the side effects of estradiol and progesterone?

Common side effects of estradiol and progesterone include Breast tenderness, Vaginal bleeding or spotting, Headache, Nausea, Increased risk of venous thromboembolism, Increased risk of breast cancer (with prolonged use).

What does estradiol and progesterone target?

estradiol and progesterone targets Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR) and is a Hormone replacement therapy (HRT).

Related

• Drug class: All Hormone replacement therapy (HRT) drugs
• Target: All drugs targeting Estrogen receptor alpha (ERα), Estrogen receptor beta (ERβ), Progesterone receptor (PR)
• Manufacturer: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — full pipeline
• Therapeutic area: All drugs in Endocrinology / Women's Health
• Indication: Drugs for Menopausal vasomotor symptoms (hot flashes, night sweats)
• Indication: Drugs for Postmenopausal osteoporosis prevention
• Indication: Drugs for Genitourinary atrophy and related symptoms
• Also known as: Estradiol Valerate, Progynova, corpus luteum hormone, luteal hormone, 3,20-pregnene-4; 4-pregnene-3,20-dione