Data updated: May 26, 2026
MILPROSA (progesterone)
Women's Health
Approved 2020-04-29
1
Indication
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2020-04-29
- Patent Cliff
- 2030
- Routes
- VAGINAL
- Dosage Forms
- SYSTEM
MILPROSA Approval History
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2020 to 2020
What MILPROSA Treats
1 FDA approvalsOriginally approved for its first indication in 2020 .
- Other (1)
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Clinical Trial Registry
62 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 |
| 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) |
| NCT01670929 | PPROURM | Ph 4 | completed | Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage |
Showing 50 of 62 trials
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Completed studies with published results, ranked by significance
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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.
MILPROSA FDA Label Details
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3 OB patents · 1 families ·
74 international docs across 26 countries
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.