Data updated: May 26, 2026
CRINONE (progesterone)
Women's Health
Approved 1997-05-13
CRINONE is indicated for the treatment of Infertility; Progesterone Deficiency; Secondary Amenorrhea.
Source: FDA Label • WATSON LABS INC
2
Indications
--
Phase 3 Trials
1
Priority Reviews
29
Years on Market
Details
- Status
- Prescription
- First Approved
- 1997-05-13
- Routes
- VAGINAL
- Dosage Forms
- GEL
CRINONE Approval History
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
41 FDA actions from 1997 to 2015
Sep 2015 SUPPL
Mfg · Manufacturing (CMC)
Mar 2014 SUPPL
Mfg · Manufacturing (CMC)
Dec 1998 SUPPL Priority
Mfg
May 1998 SUPPL
Label
Feb 1998 SUPPL Priority
Mfg
Dec 1997 SUPPL Priority
Mfg
Dec 1997 SUPPL Priority
Mfg
Jul 1997 ORIGINAL
New Form
May 1997 ORIGINAL Priority
New Form
What CRINONE Treats
3 indicationsCRINONE is approved for 3 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Infertility
- Progesterone Deficiency
- Secondary Amenorrhea
Source: FDA Label
CRINONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
2
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CRINONE
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
63 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06668896 | DARE-PTB1-001 1R44HD101169-01A1 | Ph 1 | not yet recruiting | Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert |
| NCT06851754 | 10002141 002141-CH | Ph 3 | recruiting | Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency |
| NCT07508657 LIFT | 05112025 2025-524327-53-00 | Ph 4 | not yet recruiting | Progesterone Supplementation After Letrozole-stimulated Insemination |
| NCT04675788 | 2005890134 1R01HL153114-01 | Ph 4 | completed | Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening |
| NCT04499131 PROGENDO | 1901-VLC-014-EL | Ph 4 | completed | Impact of Different Doses and Routes of Exogenous Progesterone Administration on Endometrial Receptivity Parameters |
| NCT06807580 | STUDY00006161 2025P011358 | Ph 2 | recruiting | Progesterone in Gender Affirming Hormone Therapy Study |
| NCT05704036 STURDY | IRB00307525 | Ph 4 | recruiting | Estrogen Supplementation and Bone Health in Women With CF |
| NCT06610305 PEAR | 24-1715 1R01MH122446 | Ph 4 | recruiting | Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression |
| NCT07162961 | New IVF | Ph 3 | not yet recruiting | Nintedanib for Improving Reproductive Outcomes in Adenomyosis |
| NCT03834883 results posted | 1806935117 | Ph 4 | completed | Reducing the Risk of Drug-Induced QT Interval Lengthening in Women |
| NCT06631547 | Pgs in head trauma | Ph 1 | not yet recruiting | Effect of Progesterone Administration on Severely Head Injured Patients |
| NCT03018366 results posted | PRO26081 | Ph 2 | completed | Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women |
| NCT05903820 REBEL | NL83336.018.23 | Ph 4 | completed | Rhythmic Estradiol and Bone Health |
| NCT04209543 | MIT-Do001-C301 | Ph 3 | completed | Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I) |
| NCT05286554 | 0201599 | Ph 4 | completed | Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support |
| NCT04997525 ESTRO-FET | 2020-001218-39 | Ph 4 | completed | Estradiol and Progesterone Levels Following Frozen Embryo Transfer |
| NCT06091436 ANGAS | GenSci094-301 | Ph 3 | completed | To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference |
| NCT01143064 SyNAPSe results posted | BHR-100-301 2010-018283-16 | Ph 3 | completed | Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury |
| NCT03858049 results posted | MS200113_0005 | Ph 4 | terminated | Efficacy and Safety of Crinone Versus Combination Medication (ACCESS) |
| NCT03729869 results posted | Pro00081360 2U54DA016511-16 | Ph 2 | completed | Impact of Progesterone on Stress Reactivity and Cannabis Use |
| NCT04414761 | JIAI 2020-06 | Ph 3 | completed | Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response |
| NCT02133573 results posted | 13-010710 | Ph 2 | completed | Randomized Trial of Maternal Progesterone Therapy |
| NCT03619707 | AmericanUBMC-CWET | Ph 4 | completed | Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles |
| NCT03930212 Prothreat | Prog133077 | Ph 4 | completed | Progesterone Supplementation in Threatened Abortion |
| NCT02187224 results posted | 1603017361 24330 | Ph 2, Ph 3 | completed | Progesterone Effect on Individuals Diagnoses With AD and PTSD. |
| NCT01954966 results posted | 811940 K24DA030301 | Ph 4 | completed | Progesterone and Brain Imaging Study |
| NCT04507022 | RFC041120190008 | Ph 4 | completed | The Outcome of Two Protocols Used to Prepare Endometrium for Frozen Embryo Transfer |
| NCT04537078 results posted | 0201350 | Ph 3 | completed | Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders |
| NCT01599494 | P07056 MK-8962-029 | Ph 3 | withdrawn | An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029) |
| NCT03463252 | ZHENG Ying | Ph 2, Ph 3 | recruiting | Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC |
| NCT02846909 | PCR | Ph 2 | completed | The Vaginal Progesterone and Cerclage |
| NCT02145767 | PRMT15 | Ph 2 | completed | Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial |
| NCT01441635 results posted | M12-663 | Ph 2 | completed | Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids |
| NCT04748562 | MS 483/2019 | Ph 4 | completed | Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies |
| NCT03540225 POPPET | 2016.594-T | Ph 3 | withdrawn | Vaginal Progesterone for the Prevention of Preterm Birth in Twins |
| NCT02697331 | AIN-2222-RCT | Ph 3 | completed | Vaginal Progesterone in Twin With Short Cervix |
| NCT02255175 PEERS results posted | 13-3572 K12HD001441-15, K23MH105569-01A1 | Ph 4 | completed | Perimenopausal Effects of Estradiol on Reward Responsiveness |
| NCT02032797 PROFETA-5 | PROFETA-5 | Ph 4 | completed | Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved(Frozen)-Thawed Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone. |
| NCT01940653 PROFETA-3 | PROFETA-3 | Ph 4 | completed | Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved (Frozen)-Thawed Day 3 Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone |
| NCT02513940 results posted | 1507526854 | Ph 4 | completed | Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes |
| NCT01942668 REPLENISH results posted | TXC12-05 REPLENISH Trial | Ph 3 | completed | A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms |
| NCT01809639 results posted | IRB00021983 | Ph 4 | completed | Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion |
| NCT02950935 | 16I-Prg06 | Ph 3 | terminated | Progesterone in Threatened Abortion |
| NCT02841137 | 16CDN-Prg02 | Ph 2 | completed | Efficacy Study of Progesterone Tablet in Post-menopausal Women |
| NCT02736032 | 12016 | Ph 3 | completed | Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist |
| NCT02019589 SPRY | TXP13-01 | Ph 3 | terminated | A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea |
| NCT01972464 results posted | 1305012130 R21DA035924 | Ph 2 | completed | Progesterone for Smoking Relapse Prevention Following Delivery |
| NCT02950948 | 16I-Prg05 | Ph 3 | withdrawn | Progesterone in Luteal Phase Deficiency |
| NCT00946088 results posted | SU-03312009-2078 11625 | Ph 2, Ph 3 | terminated | Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial |
| NCT00646802 PROMISE | PROMISE | Ph 4 | completed | Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study) |
Showing 50 of 63 trials
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Pro Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CRINONE FDA Label Details
Indications & Usage
FDA Label (PDF)CRINONE is indicated for the treatment of Infertility; Progesterone Deficiency; Secondary Amenorrhea.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.