Crinone 8%

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Crinone 8%

This overview defines Crinone 8% by its core identity, composition, and general purpose, strictly avoiding details on dosage, administration, side effects, or specific clinical outcomes.

Property Description
Active Ingredient Micronized Progesterone
Form Bioadhesive Vaginal Gel (8% concentration)
Pharmacological Class Progestin / Endogenous Steroid
General Purpose Endometrial support for early pregnancy
Origin Natural (chemically identical to endogenous hormone)

What Type of Medicine is Crinone 8%?

Crinone 8% is a prescription-only pharmaceutical preparation that delivers the hormone progesterone to the body. Its active ingredient is micronized progesterone. This medication is categorized as a progestin, which is the pharmacological class for substances that elicit biological responses similar to the naturally occurring progesterone hormone. The progesterone supplied is considered natural progesterone because it is structurally and chemically identical to the endogenous steroid produced by the human corpus luteum, ensuring the body utilizes the supplied hormone in the same essential manner as its own.


The Bioadhesive Vaginal Gel Form

The medication is supplied as a bioadhesive vaginal gel at an 8% concentration, specifically designed for intravaginal administration. The key feature of its bioadhesive formulation is its engineering with polymers that cause it to adhere securely to the vaginal mucosa. This design is clinically recognized for providing a reliable, slow-release profile, establishing a local reservoir from which the progesterone is released continuously over a prolonged period. The specialized delivery system is designed to provide stable, sustained absorption, differentiating it from oral or non-adhesive topical applications.


Crinone 8%'s General Purpose

The general purpose of Crinone 8% is to establish and maintain a critical physiological condition within the uterus necessary for the support of early pregnancy—a need frequently encountered in procedures like in vitro fertilization (IVF). Progesterone is fundamental for promoting the transformation of the uterine lining, the endometrium, into the secretory phase. This essential change in the endometrium is required for fostering a receptive and supportive environment. The administration of this progestin helps ensure that this vital supportive stage of the reproductive cycle is properly maintained for individuals requiring supplementation.

What side effects are possible with Crinone 8%?

Possible Side Effects and Safety Information

The safety profile of Crinone 8% (Progesterone Gel) is officially classified by regulatory authorities based on the physiological systems affected and the frequency of occurrence documented in clinical studies. The majority of reported adverse reactions are mild to moderate in nature.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to standard regulatory frequency categories:

  • Common (may affect up to 1 in 10 users): Effects often involve the central nervous system (e.g., headache, somnolence or drowsiness) and the gastrointestinal system (e.g., abdominal pain, nausea, abdominal distension). Breast tenderness and application site discomfort, such as cramping, are also commonly reported.

  • Uncommon (may affect up to 1 in 100 users): Rarer effects include vomiting, hypersensitivity reactions, and vaginal discharge.

Serious Adverse Reactions and Safety Constraints

The official labeling notes the potential for serious, though rare, systemic events and specific safety constraints:

  • Thromboembolic Disorders: Progesterone products carry a documented risk of thromboembolic events (blood clots), which may manifest as deep vein thrombosis, pulmonary embolism, or retinal thrombosis. Discontinuation is required if these events are suspected.

  • Contraindications: Crinone 8% is contraindicated in specific medical conditions as defined by regulatory bodies. These include known or suspected severe hepatic impairment or liver disease, undiagnosed vaginal bleeding, and a history of certain thromboembolic disorders.

  • Administration Safety Pattern: Due to its bioadhesive formulation, the gel may accumulate and result in a white, beige, or brownish clumpy discharge that can persist for several days after administration.

Overdose and Emergency Response

Overdose Scope

Category Official Regulatory Statements
Documented overdose presentations No reports of overdosage with Crinone have been documented in clinical experience [Medsafe].
Physiological systems affected None explicitly listed. Acute overdosage is considered unlikely due to the formulation's rate-limited absorption by the vaginal epithelium [Medsafe].
Dose-related or exposure-related factors Unlikely due to the formulation's prolonged release characteristics [Medsafe].
Population-specific overdose notes None documented in the official overdose section.
Emergency-response statements The mandated action is to discontinue CRINONE and seek immediate medical attention [Health Canada].
When immediate medical help is required If overdosage is suspected, get medical care right away [Health Canada].

Overdose Classifications (High-Level)

Category Official Regulatory Statements
Severity classification No specific severity classification is documented due to the absence of reported cases.
Regulatory basis Based on approved Prescribing Information/Data Sheets from government bodies (e.g., FDA, Medsafe).
Overdose-context constraints Management is restricted to symptomatic and supportive treatment [Medsafe].

Resulting Overdose Structure

Official overdose statements:

  • There have been no reports of overdosage with Crinone in documented experience.
  • Acute overdosage is considered unlikely due to the vaginal gel's concentration-dependent, rate-limited absorption and prolonged release properties.
  • Upon suspicion of overdosage, the mandated action is to discontinue CRINONE immediately.
  • Management of a suspected overdose is limited to symptomatic and supportive treatment, as no specific antidote is known or defined in the labeling.
  • Users are required to contact a poison control center or emergency services immediately if overdosage is suspected.

Connection to the overall overdose profile: Regulatory documents define the overdose profile by the absence of documented symptoms and a low acute risk, which is attributed to the product's slow-release design. This profile necessitates a low threshold for emergency action, mandating the immediate discontinuation of the product and professional medical consultation for supportive care, exactly as written in official regulatory text.

Therapeutic Uses of Crinone 8%

Crinone 8% (progesterone gel) provides targeted therapeutic support in specific conditions where symptoms and clinical outcomes are linked to insufficient natural progesterone. The medication is used to provide supportive therapeutic benefit by addressing patterns of hormonal deficiency, and is commonly used to help with needs in fertility treatment.

The medication is applied across domains where additional symptomatic support is needed in the context of an Assisted Reproductive Technology (ART) procedure.


Supportive Management and Therapeutic Benefits

Crinone 8% is relevant for managing symptoms related to systemic imbalance in conditions characterized by periods of heightened symptoms. The core therapeutic domains include supportive management in Assisted Reproductive Technology (ART) and addressing symptomatic manifestations of Luteal Phase Deficiency (LPD). The application supports patients during difficult episodes by easing distress and is commonly used when short-term symptomatic assistance is needed.

The application is relevant in contexts involving heightened systemic burden and provides support that aids in easing the overall symptom load. In these situations, the medication is applied in scenarios where additional management of discomfort is required, assisting with maintaining functional stability.


Quick Fact: Support for Symptom Manifestations


Specific Indications

Crinone 8% is applied across domains where additional symptomatic support is needed in contexts involving heightened systemic burden. The medication is relevant for easing symptom patterns associated with progesterone insufficiency when supportive symptom management is appropriate or when providing progesterone supplementation as part of an ART cycle, such as In Vitro Fertilization (IVF).

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Crinone 8% — Official Regulatory Information

Eligibility Scope Status Defined by Regulators
Populations for whom use is allowed Adult women requiring progesterone supplementation as part of an Assisted Reproductive Technology (ART) procedure [2.6, 1.6].
Age-related eligibility rules Not applicable or contraindicated in the pediatric population [2.4, 2.6]. Use in the geriatric population is not established [1.10].
Pregnancy and lactation eligibility Permitted for use during early pregnancy (first trimester or equivalent) for luteal phase support [2.5, 1.7]; Not recommended during lactation [2.4, 1.1].

Populations for Whom Use is Contraindicated

Crinone 8% is strictly contraindicated for individuals with the following official exclusions [2.6, 1.4]:

  • Hypersensitivity to progesterone or any excipient in the gel [2.6].
  • Active or history of thrombophlebitis or thromboembolic disorders (e.g., stroke, blood clots) [1.4].
  • Undiagnosed vaginal bleeding [2.6].
  • Known or suspected malignancy of the breast or genital organs [2.6].
  • Missed abortion (known fetal death) or ectopic pregnancy [1.4].
  • Severe hepatic dysfunction or disease (liver problems) [1.4].

Eligibility-Related Restrictions

Careful observation is required for patients with conditions that may be influenced by progestogen-induced fluid retention, such as asthma, epilepsy, cardiac, or renal dysfunction [2.1]. Patients with a history of psychic depression must also be carefully observed [2.1].

Connection to the overall eligibility profile: Official regulatory documents define who can and cannot use this medicine primarily through a list of absolute contraindications tied to life-threatening conditions or malignancies, establishing clear non-eligibility boundaries. Eligibility is confined to adult women in the context of reproductive health, with specific restrictions placed on patients with pre-existing organ dysfunction or conditions susceptible to fluid retention, mandating conditional use and careful observation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation for Crinone 8% (progesterone gel) focuses primarily on two interaction domains: local administration constraints and the official assessment of systemic metabolic risk.


Documented Interaction Patterns

Interaction Type Officially Documented Constraint
Local Drug-Product Interaction Crinone is not recommended for use concurrently with other vaginal preparations (e.g., creams, suppositories) to preserve the integrity of the bioadhesive delivery system.
Timing-Separation Requirement If co-administration of another local intravaginal therapy is required, administration must be separated by an interval of at least 6 hours before or after Crinone application.
Systemic Metabolic Risk No significant consequences on progesterone levels is expected when Crinone vaginal gel is co-administered with CYP3A inducers, despite known interactions between these substances and oral progestogens.

Overall Interaction Profile

Official regulatory documents state that no formal drug interactions have been assessed with Crinone 8% that describe altered systemic exposure of other medicines. The use of progestogens may also worsen the manifestations of Pre-existing Porphyria, leading to a formal recommendation against its use in this specific metabolic condition. The resulting interaction structure is defined by the mandated timing separation rule, which ensures the physical integrity of the local formulation, rather than systemic drug-drug interaction warnings.

Mechanism of Action

Crinone 8% contains progesterone, a naturally occurring steroid hormone. Upon administration, the progesterone is absorbed, achieving selective accumulation within target cells, notably those in the endometrium. Progesterone functions as a full agonist for the intracellular Progesterone Receptor (PR), which exists as two major isoforms, PR-A and PR-B.

The progesterone ligand binds to the cytosolic PR, inducing a conformational change in the receptor complex. This binding event triggers the dissociation of heat shock proteins and facilitates the dimerization of the activated PR. The dimeric, ligand-bound PR complex then translocates into the cell nucleus, where it binds to specific DNA sequences known as Progesterone Response Elements (PREs) located in the promoter regions of target genes. This binding modulates gene transcription, altering the synthesis rates of specific messenger RNA (mRNA) and subsequent protein synthesis.

Intracellularly, this transcriptional modulation influences the cellular architecture and secretory activity. System-level physiological consequences include the stabilization and maturation of the endometrial lining (decidualization), altering tissue receptivity through modification of local protein expression.

Dosage and Administration Information

Administration Guidelines for Crinone 8%

The usage of Crinone 8% (progesterone gel) is defined by a standardized, fixed-dose protocol based on the specific regimen required for hormonal support, primarily in the context of Assisted Reproductive Technology (ART) cycles. The medication is prepared as an 8% bioadhesive vaginal gel and is exclusively designed for intravaginal administration using a pre-filled, single-use applicator.

Official Dosing and Frequency

The fixed dose delivered is 90 mg of micronized progesterone per application. This dose is administered according to one of two main frequency patterns:

  • Once Daily: Typically used for progesterone supplementation regimens in infertile women.
  • Twice Daily: Employed for progesterone replacement in women with ovarian failure undergoing ART procedures, such as In Vitro Fertilization (IVF).

Administration for both regimens commences during the luteal phase of the treatment cycle, such as the day following ovum retrieval or the start of the required hormonal program.

Procedural and Course Instructions

Administration requires preparation of the applicator by shaking it down vigorously before the seal is broken to ensure the gel is ready for delivery. Each applicator is for one dose only and must be discarded immediately after use. It is specified that the 90 mg application must follow the predetermined schedule, and a missed dose should not be doubled to compensate.

If pregnancy is confirmed, the treatment course is generally continued for a defined period, typically for up to 10 to 12 weeks of gestation. Concomitant use with other vaginal products is generally advised against, with a recommended waiting period of at least six hours if necessary. The official labeling does not specify numerical dose adjustments for use in pediatric or older adult populations.

Recent Clinical Evidence

Research evidence / Overview of Studies for Crinone 8%


Evidence for Use in Assisted Reproductive Technology (ART) Cycles

The primary research for Crinone 8% has explored its use in studies examining supportive management during Assisted Reproductive Technology (ART) procedures, such as In Vitro Fertilization (IVF) and embryo transfer. Studies exploring this use include Randomized Controlled Trials (RCTs) and prospective comparative studies. These trials were applied in research contexts involving women undergoing fertility treatment who were receiving support for the uterine lining.

Researchers designed these studies to monitor key outcomes related to pregnancy status. The trials examined high-level clinical outcomes, including the Live Birth Rate, Ongoing Pregnancy Rate, and Clinical Pregnancy Rate following the transfer of an embryo. Comparative research described patterns observed when Crinone 8% was used alongside other forms of progesterone delivery, such as intramuscular injections.


Research on Endometrial Support

Research has also explored the specific physiological patterns observed in the uterus following the use of Crinone 8%. This evidence is derived from specialized pharmacodynamic (PD) studies and trials that involved examining the uterine lining, known as the endometrium, through histological assessment.

Studies explored whether the drug was associated with the necessary transformation of the uterine lining into the secretory phase, which is a functional requirement. The focus on endometrial tissue status in these studies means that the findings are based on a surrogate endpoint; the final clinical success (like a live birth) is an outcome monitored in the larger ART trials.


Research Gaps and Areas of Uncertainty

The body of research contains several areas where further data collection is needed. Evidence quality varies across studies, and one noted limitation is that some of the earlier regulatory trials were conducted using an open-label design. Furthermore, comparative evidence in the main trials often focuses on demonstrating non-inferiority (meaning the drug performs similarly) when compared to commonly used methods.

Research contributes to understanding short-term changes observed during the study period, but there is limited information for long-term outcomes regarding the health of children born following the use of this drug.

Key Studies & References

  1. A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET) (NCT01081652)

Frequently Asked Questions (FAQ)

Common questions about Crinone 8% (FAQ)


Q: Does Crinone 8% interact with common pain relievers like ibuprofen?

A: According to official product information, no formal systemic drug interactions have been assessed with other medicines, including common over-the-counter pain relievers. The key documented constraint notes that a 6-hour separation is required if another product is inserted locally into the vagina.


Q: Is Crinone 8% safe to use for women with a history of blood clots?

A: The medication is contraindicated, meaning that regulatory labeling advises against its use in individuals with an active or past history of thromboembolic disorders. This includes conditions like thrombophlebitis or cerebral apoplexy, which involve blood clots or stroke.


Q: What is the difference between Crinone 8% and other progesterone treatments?

A: Crinone 8% is formulated as a bioadhesive vaginal gel, which allows it to stick to the vaginal walls and release the hormone over time. The 8% concentration is specifically indicated for progesterone support during Assisted Reproductive Technology (ART) procedures, while the 4% concentration is indicated for a different condition, secondary amenorrhea.


Q: Does Crinone 8% interact with common supplements like prenatal vitamins?

A: Official documents state that no formal systemic drug interactions have been assessed with other medicines, which includes supplements and prenatal vitamins. The key constraint is that co-administration with other local vaginal preparations is not recommended, and a 6-hour separation is required if necessary.


Q: Does Crinone 8% interact with antibiotics or antifungal medication?

A: Official documents state that no formal systemic drug interactions have been assessed with other medicines like antibiotics. However, co-administration with other vaginal preparations (which may include antifungal creams or suppositories) is not recommended. A 6-hour interval is mandated for separation if another local vaginal treatment is also used.


Q: Why does the package insert mention a risk of vision changes?

A: Official warnings include sudden changes in vision or speech among the serious signals that may indicate a thromboembolic event, which is a blood clot. While rare, these are considered critical signs that require immediate medical evaluation and discontinuation of the medication.


Q: Is it normal to have lower progesterone levels in the blood while using Crinone 8%?

A: Pharmacokinetic studies indicate that the bioadhesive design results in prolonged and sustained absorption of progesterone from the vaginal wall. Because of this localized delivery method, the concentrations of progesterone measured in the blood serum may naturally differ from those seen when using other administration routes.


Q: What is the expected timeline for starting Crinone 8% after an egg retrieval procedure?

A: According to official prescribing information, the timing is described as beginning during the luteal phase of the treatment cycle, such as the day following ovum retrieval or the beginning of the required hormonal program.


Q: Can using Crinone 8% cause mood changes or depression?

A: Yes, official data reports that depression and emotional lability (mood swings) have been noted as treatment-emergent adverse events in clinical trials. Furthermore, the labeling indicates that patients with a history of psychic depression are conditions requiring careful observation.


Q: How quickly does Crinone 8% start working after I begin using it?

A: Pharmacokinetic studies indicate that the drug begins working soon after administration. A stable concentration of the drug in the body, known as steady state, is generally achieved within the first 24 hours after beginning the treatment regimen.


Q: Are there any foods or drinks that should be avoided while using Crinone 8%?

A: There is no specific regulatory restriction against particular foods or drinks mentioned in the Crinone 8% product information. However, progesterone (the active ingredient) is associated with a general caution regarding the intake of grapefruit juice.


Q: Can Crinone 8% be used if someone is allergic to peanuts?

A: Official regulatory documents list all excipients, or inactive ingredients, in the gel, which include substances like glycerin and sorbic acid. Known hypersensitivity or allergy to progesterone or any of the excipients in the gel is listed as a contraindication (a reason regulatory bodies advise against the drug's use).


Q: Is there a risk of developing yeast infections while using Crinone 8%?

A: Yes, official safety data notes that Genital Moniliasis (also known as vaginal thrush or yeast infection) and Vaginal Mycosis are reported in clinical trials as a possible Common or Uncommon adverse effect.


Q: What is the difference between the 4% and 8% concentration of Crinone?

A: The two concentrations are indicated for different uses based on regulatory approval. Crinone 4% is indicated for the treatment of secondary amenorrhea (lack of a menstrual period), while Crinone 8% is indicated for progesterone support in women undergoing Assisted Reproductive Technology (ART).


Q: Does Crinone 8% contain any preservatives that people might be sensitive to?

A: Yes, the gel contains the excipient sorbic acid, which functions as a preservative. Official documents note that this ingredient may cause local skin reactions such as contact dermatitis or vaginal irritation in some individuals.


Q: How does the use of Crinone 8% relate to a corpus luteum deficiency?

A: Crinone 8% is used to provide essential progesterone supplementation for a condition commonly called luteal phase deficiency/insufficiency. This condition is related to the corpus luteum, a temporary structure in the ovary, not producing sufficient progesterone to fully support the uterine lining.


Q: Are there any reported cases of serious allergic reactions to Crinone 8%?

A: Hypersensitivity reactions are reported as an Uncommon adverse effect, usually presenting as a localized skin rash or mild reaction. Post-marketing surveillance has also noted rare reports of anaphylactic reaction, which is a severe and life-threatening allergic reaction.


Q: Can Crinone 8% usage lead to fluid retention or bloating?

A: Yes, bloating and abdominal distension are commonly reported adverse events in clinical trials. Additionally, official warnings indicate that patients with conditions that may be influenced by fluid retention are listed as conditions requiring careful observation.


Q: What is known about the long-term safety profile of Crinone 8%?

A: Official documents and research summaries note that there is limited information available regarding the long-term safety outcomes of the medication. This includes the long-term health of children born following the use of the drug.


Q: Are there any restrictions on activity while using Crinone 8%?

A: Official safety information notes that drowsiness and sleepiness were reported in clinical trials. Patients are advised to exercise caution when operating machinery or driving due to the potential for drowsiness and sleepiness reported in clinical trials.


Q: Does Crinone 8% affect liver function?

A: Official documents list signs of possible liver problems as serious warning signals. These signs include the onset of jaundice (yellowing of the skin and/or eyes) or notable changes in stool/urine color, which require immediate medical attention.


Q: Is it possible for a partner to feel the Crinone residue?

A: The medication is a bioadhesive gel designed to adhere to the vaginal walls to provide sustained absorption. This application process may result in a white, beige, or brownish clumpy discharge that can persist for several days.

How should Crinone 8% be stored and disposed of?

How to Store and Dispose of Crinone 8%

Crinone 8% (progesterone gel) must be stored and handled according to regulatory requirements to ensure product integrity and safety.


Official Storage Conditions

The product must be stored at Controlled Room Temperature (20 C to 25 C) with permitted excursions up to 30 C. It is mandatory to keep out of the sight and reach of children. The gel must be stored in its original container and should not be frozen. Storage beyond the expiry date shown on the carton is prohibited.


Disposal Instructions

Crinone 8% is supplied in a single-use applicator that should be discarded in a waste container immediately after use. Unused or expired gel must not be thrown away via wastewater or general household waste. Instead, unused medication must be returned to a pharmacist or healthcare provider for proper disposal, following local environmental regulations for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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