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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR CRINONE


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All Clinical Trials for Crinone

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00505752 ↗ Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART) Completed Merck KGaA Phase 2 2007-01-01 This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
NCT00505752 ↗ Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART) Completed Merck KGaA, Darmstadt, Germany Phase 2 2007-01-01 This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
NCT00296478 ↗ Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF) Completed Ferring Pharmaceuticals Phase 3 2005-07-01 This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
NCT00117468 ↗ Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement Completed Duramed Research Phase 2 2005-06-01 This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.
NCT00086177 ↗ Vaginal Progesterone to Reduce the Risk of Another Preterm Birth Completed Juniper Pharmaceuticals, Inc. Phase 3 2004-04-01 This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. All study medications will be given vaginally once a day. Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for Crinone

Condition Name

112220-10123456789101112InfertilityPolycystic Ovary SyndromeFertilityPregnancy[disabled in preview]
Condition Name for Crinone
Intervention Trials
Infertility 11
Polycystic Ovary Syndrome 2
Fertility 2
Pregnancy 2
[disabled in preview] 0
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Condition MeSH

14222002468101214InfertilityInfertility, FemalePolycystic Ovary SyndromePremature Birth[disabled in preview]
Condition MeSH for Crinone
Intervention Trials
Infertility 14
Infertility, Female 2
Polycystic Ovary Syndrome 2
Premature Birth 2
[disabled in preview] 0
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Clinical Trial Locations for Crinone

Trials by Country

+
Trials by Country for Crinone
Location Trials
United States 29
China 4
Israel 3
Italy 2
Germany 2
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Trials by US State

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Trials by US State for Crinone
Location Trials
Massachusetts 4
Virginia 3
Illinois 2
North Carolina 2
New York 1
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Clinical Trial Progress for Crinone

Clinical Trial Phase

45.5%36.4%13.6%012345678910Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Crinone
Clinical Trial Phase Trials
Phase 4 10
Phase 3 8
Phase 2/Phase 3 1
[disabled in preview] 3
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Clinical Trial Status

54.5%27.3%9.1%9.1%012345678910111213CompletedUnknown statusTerminated[disabled in preview]
Clinical Trial Status for Crinone
Clinical Trial Phase Trials
Completed 12
Unknown status 6
Terminated 2
[disabled in preview] 2
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Clinical Trial Sponsors for Crinone

Sponsor Name

trials011223344Merck KGaA, Darmstadt, GermanyMerck KGaABrigham and Women's Hospital[disabled in preview]
Sponsor Name for Crinone
Sponsor Trials
Merck KGaA, Darmstadt, Germany 4
Merck KGaA 3
Brigham and Women's Hospital 2
[disabled in preview] 4
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Sponsor Type

63.5%36.5%005101520253035OtherIndustry[disabled in preview]
Sponsor Type for Crinone
Sponsor Trials
Other 33
Industry 19
[disabled in preview] 0
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CRINONE: Clinical Trials, Market Analysis, and Projections

Introduction

CRINONE, a progesterone vaginal gel, is a crucial medication in the field of reproductive health, particularly in assisted reproductive technology (ART) and the treatment of infertility. Here, we will delve into the clinical trials, market analysis, and projections for CRINONE.

Clinical Trials Overview

Assisted Reproductive Technology (ART)

CRINONE has been extensively studied in the context of ART. In a single-center, open-label study (COL1620-007US), 99 women with partial or premature ovarian failure undergoing donor oocyte transfer were randomized to receive either CRINONE 8% twice daily or intramuscular progesterone 100 mg daily. The study showed that CRINONE 8% effectively primed the endometrium and supported pregnancy, with clinical pregnancies occurring in 48% of the women treated with CRINONE 8%[1].

In another study (COL1620-F01), CRINONE 8% was used for luteal phase support in women undergoing in vitro fertilization (IVF). Here, 139 women received CRINONE 8% once daily beginning within 24 hours of embryo transfer, and clinical pregnancies were observed in 26% of the women at Day 90 post-transfer[1].

Endometrial Response and Pregnancy Outcomes

The efficacy of CRINONE in inducing a secretory transformation of the endometrium has been consistently demonstrated. In a study where women received CRINONE every other day for six doses, endometrial biopsies showed that CRINONE induced a secretory transformation in a significant proportion of the women, despite relatively low plasma progesterone concentrations. This suggests a preferential distribution of transvaginally administered progesterone or a First Uterine-Pass Effect[3].

Adverse Reactions

Clinical trials have shown that the adverse effects of CRINONE are generally mild and transient. Common adverse reactions include pruritis, rash, skin disorder, and urticaria, which are qualitatively similar to those of natural progesterone but occur at a lower frequency[3].

Pharmacokinetics and Bioavailability

The pharmacokinetics of CRINONE highlight its efficient delivery mechanism. When administered vaginally, CRINONE achieves higher bioavailability compared to oral progesterone capsules, avoiding significant first-pass metabolism. The average peak serum concentration of CRINONE 90 mg administered twice daily was 14.6 ng/mL, with a steady-state concentration of 11.6 ng/mL. This consistent delivery is attributed to CRINONE’s bioadhesive and sustained release properties[3].

Market Analysis

Global Market Size and Growth

The progesterone market, which includes CRINONE, is projected to grow significantly. As of 2024, the market size is estimated at USD 1.74 billion and is expected to reach USD 2.67 billion by 2029, growing at a CAGR of 8.92% during the forecast period[5].

Regional Dominance

North America is expected to dominate the progesterone market due to the increasing adaptability of advanced treatments and a high disease burden, including cases of uterine body cancers and menopausal women. The Asia Pacific region is identified as the fastest-growing market, driven by emerging healthcare needs and economic growth[5].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the progesterone market. Studies suggesting the effectiveness of progesterone in reducing the severity of COVID-19 in hospitalized men increased demand for progesterone treatments, contributing to market growth during the pandemic[5].

Market Projections

Increasing Demand for Advanced Treatments

The demand for progesterone, including CRINONE, is expected to rise due to the increasing focus on target disorders such as infertility, menopausal symptoms, and certain types of cancer. Advanced treatments and collaborative efforts among market players to enhance R&D capabilities will drive this growth[5].

Expanding Geographic Reach

CRINONE is currently approved in 63 countries, including China, where it was approved in 2008. The renewal of the license and supply agreement between Columbia Laboratories and Merck Serono ensures continued marketing efforts worldwide, except in the United States, where Columbia retains the marketing rights[2].

Competitive Landscape

The progesterone market is competitive, with several major players. However, CRINONE’s unique delivery mechanism and proven efficacy in clinical trials position it as a significant player in the market. The successful marketing of CRINONE by Merck Serono outside the United States and the anticipated growth in emerging markets are expected to contribute to its market share[2][5].

Key Takeaways

  • Clinical Efficacy: CRINONE has demonstrated strong efficacy in ART procedures, including IVF and donor oocyte transfer, with significant clinical pregnancy rates.
  • Pharmacokinetics: CRINONE’s vaginal delivery mechanism ensures higher bioavailability and consistent progesterone levels compared to oral or intramuscular administration.
  • Market Growth: The progesterone market, including CRINONE, is projected to grow at a CAGR of 8.92% from 2024 to 2029, driven by increasing demand for advanced treatments and expanding geographic reach.
  • Regional Dominance: North America is expected to dominate the market, while the Asia Pacific region will experience the fastest growth.

FAQs

What is CRINONE used for?

CRINONE is used for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatments for infertile women with progesterone deficiency.

How is CRINONE administered?

CRINONE is administered vaginally, using a bioadhesive gel that ensures sustained release of progesterone.

What are the common adverse reactions to CRINONE?

Common adverse reactions include pruritis, rash, skin disorder, and urticaria, which are generally mild and transient.

How does CRINONE compare to other forms of progesterone in terms of bioavailability?

CRINONE has higher bioavailability compared to oral progesterone capsules due to its vaginal delivery mechanism, which avoids significant first-pass metabolism.

Which regions are expected to drive the growth of the progesterone market?

North America is expected to dominate the market, while the Asia Pacific region will experience the fastest growth due to emerging healthcare needs and economic growth.

Sources

  1. FDA Label: Crinone® 4% and Crinone® 8% - accessdata.fda.gov
  2. FiercePharma: Columbia Laboratories Renews Agreement with Merck Serono for CRINONE
  3. Health Canada: Crinone® (Progesterone 8%) - pdf.hres.ca
  4. Merck Clinical Trials: Efficacy and safety of Crinone versus combination medication
  5. Mordor Intelligence: Progesterone Market - Growth, Report, Applications & Manufacturers

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