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Progesterone

Generic Name
Progesterone
Brand Names
Bijuva, Crinone, Endometrin, Prochieve, Prometrium
Drug Type
Small Molecule
Chemical Formula
C21H30O2
CAS Number
57-83-0
Unique Ingredient Identifier
4G7DS2Q64Y
Background

Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss . Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization , as well as in other formulations to promote and support pregnancy. Please see Medroxyprogesterone acetate, Megestrol acetate, Dydrogesterone and Hydroxyprogesterone entries for information on various other forms of progesterone.

Pharmaceutical progesterone is made from a plant source as a starting material and is chemically identical to progesterone of human ovarian origin . Progesterone is available in gelatinized capsule form, vaginal gel form, tablet form, vaginal insert form, and injection form, all used for various purposes .

Indication

Gelatinized capsules

The gelatinized capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea .

Vaginal gel

Progesterone gel (8%) is indicated as progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. The lower concentration progesterone gel (4%) is used in the treatment of secondary amenorrhea, with the use of the 8% concentration if there is no therapeutic response to the 4% gel .

Vaginal insert

This form is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women .

Injection (intramuscular)

This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer .

Tablets, contraceptive

The tablet form of progesterone in contraceptive formulations is indicated for the prevention of pregnancy .

Associated Conditions
Abnormal Uterine Bleeding, Amenorrhea, Endometrial hyperplasia caused by conjugated estrogen, Moderate to Severe Vasomotor Symptoms, Pregnancy, Secondary Amenorrhea, Recurrent spontaneous preterm birth
Associated Therapies
Assisted Reproductive Technology therapy

Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders

Phase 4
Conditions
Pregnancy Early
Miscarriage
Ovarian Hyperstimulation Syndrome
Interventions
First Posted Date
2021-03-15
Last Posted Date
2021-04-01
Lead Sponsor
Assaf-Harofeh Medical Center
Target Recruit Count
100
Registration Number
NCT04797338
Locations
🇮🇱

Shamir Medical center, Be'er Ya'aqov, Israel

Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

Phase 4
Recruiting
Conditions
Smoking Reduction
Smoking Cessation
Smoking
Interventions
First Posted Date
2021-03-05
Last Posted Date
2025-01-22
Lead Sponsor
University of Minnesota
Target Recruit Count
279
Registration Number
NCT04783857
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles

Phase 4
Completed
Conditions
Frozen Embryo Transfer
Dydrogesterone
Hormone Replacement Therapy
Infertility, Female
Interventions
First Posted Date
2021-02-17
Last Posted Date
2024-06-14
Lead Sponsor
CRG UZ Brussel
Target Recruit Count
150
Registration Number
NCT04758871
Locations
🇧🇪

Brussels IVF, Brussels, Belgium

Pharmacokinetics of Progesterone in Pregnancy-2

Phase 1
Terminated
Conditions
Pregnancy Related
Interventions
First Posted Date
2021-02-15
Last Posted Date
2022-05-26
Lead Sponsor
Thomas Jefferson University
Target Recruit Count
3
Registration Number
NCT04753957
Locations
🇺🇸

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

Phase 4
Completed
Conditions
Twin Pregnancy With Antenatal Problem
Interventions
First Posted Date
2021-02-10
Last Posted Date
2021-02-10
Lead Sponsor
Ain Shams University
Target Recruit Count
100
Registration Number
NCT04748562
Locations
🇪🇬

Ain Shams University Maternity hospital, Cairo, Egypt

the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes

Completed
Conditions
Female Infertility
Frozen-thawed Embryo Transfer
Infertility
Interventions
First Posted Date
2021-02-02
Last Posted Date
2023-01-03
Lead Sponsor
Akdeniz University
Target Recruit Count
205
Registration Number
NCT04733235
Locations
🇹🇷

Akdeniz University, Antalya, Turkey

Progesterone as Luteal Support in Frozen IVF Natural Cycles

Phase 4
Recruiting
Conditions
Infertility
Embryo Transfer
Interventions
First Posted Date
2021-01-27
Last Posted Date
2024-04-24
Lead Sponsor
Vastra Gotaland Region
Target Recruit Count
1800
Registration Number
NCT04725864
Locations
🇸🇪

Department of Reproductive Medicine, Gothenburg, Sweden

Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.

Completed
Conditions
Luteal Phase Defect
Interventions
First Posted Date
2021-01-25
Last Posted Date
2021-03-19
Lead Sponsor
Instituto Bernabeu
Target Recruit Count
347
Registration Number
NCT04722471
Locations
🇪🇸

Instituto Bernabeu, Alicante, Comunidad Valenciana, Spain

Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

Phase 4
Completed
Conditions
Long QT Syndrome
Abnormalities, Drug-Induced
Interventions
First Posted Date
2020-12-19
Last Posted Date
2025-04-29
Lead Sponsor
Indiana University
Target Recruit Count
73
Registration Number
NCT04675788
Locations
🇺🇸

Indiana Clinical Research Center, Indianapolis, Indiana, United States

🇺🇸

Indiana University, Indianapolis, Indiana, United States

🇺🇸

Purdue University, Indianapolis, Indiana, United States

Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases

Completed
Conditions
Autoimmune Diseases
Infertility
Interventions
First Posted Date
2020-12-11
Last Posted Date
2024-05-28
Lead Sponsor
San Carlo Public Hospital, Potenza, Italy
Target Recruit Count
18
Registration Number
NCT04665232
Locations
🇮🇹

Assunta Iuliano, Potenza, Italy

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