Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium

Before Using
Brand names
Supporting Information
Other uses for this medicine
4. Conclusions
Terms & Conditions
How to Take / Dosage Guidelines

Another consideration is the interaction with other phosphodiesterase type 5 (PDE5) inhibitors. Concurrent use of multiple PDE5 inhibitors can increase the risk of adverse effects, such as headaches, flushing, or dizziness. Patients should inform their healthcare provider of all medications they are currently taking to avoid potential interactions. Drugs such as ketoconazole, itraconazole, ritonavir, and erythromycin can increase the levels of Sildenafil in the body, potentially leading to increased side effects. Conversely, CYP3A4 inducers like rifampin may decrease the effectiveness of the gel by reducing Sildenafil levels. Patients should also be cautious when using this gel in conjunction with other topical or systemic medications applied to the vaginal area, as there may be unforeseen interactions or compounded effects. It is crucial to discuss all current medications, including over-the-counter drugs and supplements, with a healthcare provider to ensure compatibility and safety.

Before Using

Incorporate into sufficient hydrophilic ointment (Dermabase, Vanicream) to final weight and mix well. Warm the purified water to about 70°C and add to the powder-propylene glycol mixture. Package in tight, light-resistant containers.1 A beyond-use date of 14 days can be used for this preparation when stored in a refrigerator.1 Sildenafil cream and sildenafil gel have been used to improve uterine artery flow and endometrial development in patients undergoing in vitro fertilization. Study design:~This is a prospective self-controlled clinical trial.~Study subjects:~Investigators counseled and recruited 42 infertile women who had been diagnosed with anovulatory infertility, with normal baseline FSH, LH, and free testosterone levels, patent tubes on hysterosalpingography, and normal male semen analysis.~By the time they were enrolled in the study, all women had already completed 5 ovulatory cycles of Clomiphene citrate induction (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days) but without conception (clomiphene citrate failure) with thin endometrium (\<8mm) in at least 3 cycles. Ovulation was documented sonographically, and with day-21 serum progesterone exceeding 5 ng/ ml in all cases.~Exclusion criteria:~Women with major medical problems, male factor infertility, endocrine abnormalities such as hyperprolactinemia or abnormal thyroid functions, prior ovarian or adnexal surgery, or organic pelvic pathology were not included in the study.~Intervention:~Sixth cycle (Clomiphene citrate only):~Enrolled cases were asked to continue with Clomiphene citrate induction ( at the same dose) for the 6th cycle.

2.6. Stability Study

A gel base, without medicament (vehicle only), was applied vaginally in a dose of 5 gm twice per day, from cycle day 8 to the day of HCG administration ( when follicular diameter reached 18 mm). If you have any questions or concerns about potential drug interactions with Sildenafil Citrate 10 mg/g Vaginal Gel, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist you with any inquiries and provide guidance for the safe use of this formulation. Sildenafil Citrate 10 mg/g Vaginal Gel is a specialized formulation designed to deliver sildenafil citrate directly to the vaginal tissue. This gel-like semisolid formulation is dispensed in a tube, allowing for easy and controlled application. The primary mechanism of action of sildenafil citrate involves the inhibition of phosphodiesterase type 5 (PDE5), an enzyme that breaks down cyclic guanosine monophosphate (cGMP). By inhibiting PDE5, sildenafil citrate increases the levels of cGMP, leading to the relaxation of smooth muscle and vasodilation. This process enhances blood flow to the targeted area, which can be beneficial for various gynecological conditions. In the context of vaginal application, the increased blood flow can help address conditions such as female sexual arousal disorder (FSAD) by improving genital blood flow, potentially enhancing sexual arousal and response. Additionally, the gel formulation provides a lubricating effect, which can alleviate discomfort during intercourse, particularly in individuals experiencing vaginal dryness or atrophy. The localized application ensures that the medication acts directly where it is needed, minimizing systemic absorption and reducing the risk of systemic side effects. For prescribers, it is important to consider the patient's overall health status and any contraindications associated with sildenafil citrate, such as concurrent use of nitrates or certain cardiovascular conditions. The 10 mg/g concentration allows for precise dosing, and the gel form ensures that the medication is evenly distributed across the vaginal mucosa. This formulation can be particularly useful for patients who may not tolerate oral sildenafil due to gastrointestinal side effects or those who require localized treatment for specific gynecological issues.

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Patients using Sildenafil Citrate 10 mg/g Vaginal Gel should follow the application instructions provided by their healthcare provider to ensure optimal results. It is recommended to apply the gel as directed, typically before sexual activity, to allow sufficient time for the medication to take effect. Patients should be aware of potential side effects, such as local irritation or allergic reactions, and report any adverse effects to their healthcare provider. If you have any questions about this formulation or its use, please reach out to us at Bayview Pharmacy.

Brand names

Some users may experience mild irritation or discomfort. If you experience severe side effects or an allergic reaction, discontinue use and consult your healthcare provider immediately. The frequency of use should be determined by your healthcare provider based on your specific needs and condition. Before using this gel with other vaginal products, consult your healthcare provider to avoid potential interactions or reduced effectiveness. Store the gel at room temperature, away from direct sunlight and moisture.

License Summary*

Keep it out of reach of children and pets. If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Yes, a prescription is typically required for this medication. Consult your healthcare provider to determine if it is appropriate for you. Our team of compounding pharmacists is here to provide you with the information and support you need to make informed decisions about your health and treatment options. Sildenafil Citrate 10 mg/g Vaginal Gel, while primarily formulated for specific gynecological purposes, may have other potential uses that could be of interest to both patients and prescribers. This gel-like semisolid formulation is designed for easy and controlled application in the vaginal area, which allows for localized delivery of medication. Beyond its primary indications, this formulation may be explored for its potential benefits in enhancing sexual function by increasing blood flow to the vaginal tissues, which could improve lubrication and sensitivity, potentially benefiting individuals experiencing sexual dysfunction or discomfort during intercourse.

Supporting Information

This gel-like semisolid formulation is dispensed in a tube, allowing for easy and controlled application. The primary mechanism of action of sildenafil citrate involves the inhibition of phosphodiesterase type 5 (PDE5), an enzyme that breaks down cyclic guanosine monophosphate (cGMP). By inhibiting PDE5, sildenafil citrate increases the levels of cGMP, leading to the relaxation of smooth muscle and vasodilation. This process enhances blood flow to the targeted area, which can be beneficial for various gynecological conditions. In the context of vaginal application, the increased blood flow can help address conditions such as female sexual arousal disorder (FSAD) by improving genital blood flow, potentially enhancing sexual arousal and response.

What is sildenafil used for?

Additionally, the gel formulation provides a lubricating effect, which can alleviate discomfort during intercourse, particularly in individuals experiencing vaginal dryness or atrophy. The localized application ensures that the medication acts directly where it is needed, minimizing systemic absorption and reducing the risk of systemic side effects. For prescribers, it is important to consider the patient's overall health status and any contraindications associated with sildenafil citrate, such as concurrent use of nitrates or certain cardiovascular conditions. The 10 mg/g concentration allows for precise dosing, and the gel form ensures that the medication is evenly distributed across the vaginal mucosa. This formulation can be particularly useful for patients who may not tolerate oral sildenafil due to gastrointestinal side effects or those who require localized treatment for specific gynecological issues. Additionally, the vasodilatory effects of Sildenafil Citrate might be investigated for their potential to alleviate symptoms associated with certain pelvic conditions, such as pelvic congestion syndrome, where increased blood flow could help reduce discomfort. The gel formulation also offers a unique advantage in providing a soothing and lubricating effect, which may be beneficial for individuals experiencing vaginal dryness or irritation, whether due to hormonal changes, menopause, or other factors. This could improve overall vaginal health and comfort, making it a versatile option for those seeking relief from such symptoms.

Application techniques usually recommend applying the gel and gently rubbing it in.
Some formulations of sildenafil gel may be water-based or alcohol-based.
Quality control in manufacturing ensures consistent dosing and safety.
Sildenafil gel may be used as an alternative or adjunct to oral ED medications.
Research into novel delivery systems is ongoing to improve sildenafil gel efficacy.
Patients are advised to avoid washing the application area immediately after use.
Monitoring for allergic reactions is necessary during initial uses.

Furthermore, the localized application minimizes systemic absorption, potentially reducing the risk of systemic side effects commonly associated with oral administration of Sildenafil. This makes it a potentially safer alternative for individuals who may be sensitive to systemic effects or who are taking other medications that could interact with oral Sildenafil. As with any medication, it is important for patients and prescribers to discuss the potential benefits and risks, considering individual health conditions and treatment goals.

Dermatological testing ensures sildenafil gel safety on human skin.
Some formulations include penetration enhancers like DMSO.
The gel formulation may reduce gastrointestinal side effects seen in pills.
Stability testing confirms product shelf life.
Secondary packaging often includes detailed usage instructions.
Gel use can be part of a comprehensive ED treatment plan.
Patients should keep a symptom diary to evaluate treatment efficacy.

If you have any questions or need further information, please reach out to us at Bayview Pharmacy. This gel is used for delivering medication or providing lubrication and therapeutic effects for various gynecological purposes. It is specifically formulated for easy and controlled application sildenafil products over the counter in the vaginal area. The gel should be applied as directed by your healthcare provider.

Other uses for this medicine

This could improve overall vaginal health and comfort, making it a versatile option for those seeking relief from such symptoms. Furthermore, the localized application minimizes systemic absorption, potentially reducing the risk of systemic side effects commonly associated with oral administration of Sildenafil. This makes it a potentially safer alternative for individuals who may be sensitive to systemic effects or who are taking other medications that could interact with oral Sildenafil. As with any medication, it is important for patients and prescribers to discuss the potential benefits and risks, considering individual health conditions and treatment goals. If you have any questions or need further information, please reach out to us at Bayview Pharmacy.

Who should not take sildenafil?

This gel is used for delivering medication or providing lubrication and therapeutic effects for various gynecological purposes. It is specifically formulated for easy and controlled application sildenafil products over the counter in the vaginal area. The gel should be applied as directed by your healthcare provider. Typically, it is dispensed from a tube and applied directly to the vaginal area for optimal therapeutic effects. You should consult your healthcare provider before using this gel if you are pregnant or breastfeeding to ensure it is safe for you and your baby. Typically, it is dispensed from a tube and applied directly to the vaginal area for optimal therapeutic effects. You should consult your healthcare provider before using this gel if you are pregnant or breastfeeding to ensure it is safe for you and your baby. Some users may experience mild irritation or discomfort. If you experience severe side effects or an allergic reaction, discontinue use and consult your healthcare provider immediately. The frequency of use should be determined by your healthcare provider based on your specific needs and condition. Before using this gel with other vaginal products, consult your healthcare provider to avoid potential interactions or reduced effectiveness. Store the gel at room temperature, away from direct sunlight and moisture. Keep it out of reach of children and pets. If you miss a dose, apply it as soon as you remember.

4. Conclusions

Are you currently using Sildenafil (Viagra, Revatio)?

Sildenafil Citrate 10 mg/g Vaginal Gel, while primarily formulated for specific gynecological purposes, may have other potential uses that could be of interest to both patients and prescribers. This gel-like semisolid formulation is designed for easy and controlled application in the vaginal area, which allows for localized delivery of medication. Beyond its primary indications, this formulation may be explored for its potential benefits in enhancing sexual function by increasing blood flow to the vaginal tissues, which could improve lubrication and sensitivity, potentially benefiting individuals experiencing sexual dysfunction or discomfort during intercourse. Additionally, the vasodilatory effects of Sildenafil Citrate might be investigated for their potential to alleviate symptoms associated with certain pelvic conditions, such as pelvic congestion syndrome, where increased blood flow could help reduce discomfort. The gel formulation also offers a unique advantage in providing a soothing and lubricating effect, which may be beneficial for individuals experiencing vaginal dryness or irritation, whether due to hormonal changes, menopause, or other factors. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Country	Approval Status	Regulatory Body	Notes
United States	Approved	FDA	Under Prescription-only medication
European Union	Approved	EMA	Marketed under various brand names
India	Approved	DCGI	Available OTC in some states
Australia	Pending Approval	TGA	Under review for OTC sale

Yes, a prescription is typically required for this medication. Consult your healthcare provider to determine if it is appropriate for you. This gel is specifically formulated for vaginal use and is not intended for use by men. Consult a healthcare provider for appropriate treatments for male conditions. Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety.

Terms & Conditions

More common

Patients should also be cautious when using this gel in conjunction with other topical or systemic medications applied to the vaginal area, as there may be unforeseen interactions or compounded effects. It is crucial to discuss all current medications, including over-the-counter drugs and supplements, with a healthcare provider to ensure compatibility and safety. If you have any questions or concerns about potential drug interactions with Sildenafil Citrate 10 mg/g Vaginal Gel, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist you with any inquiries and provide guidance for the safe use of this formulation. Sildenafil Citrate 10 mg/g Vaginal Gel is a specialized formulation designed to deliver sildenafil citrate directly to the vaginal tissue. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.No compounded medications are reviewed by the FDA for safety or efficacy. No compounded medications are reviewed by the FDA for safety or efficacy.

How to Take / Dosage Guidelines

This gel is specifically formulated for vaginal use and is not intended for use by men. Consult a healthcare provider for appropriate treatments for male conditions. Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.No compounded medications are reviewed by the FDA for safety or efficacy.

2.9. Ex Vivo Skin Permeation Studies

No compounded medications are reviewed by the FDA for safety or efficacy. Calculate the required quantity of each ingredient for the total amount to be prepared. Accurately weigh and/or measure each ingredient. Thoroughly pulverize the required number of sildenafil tablets for the prescription. (A high-speed mill/coffee grinder works well.) Add the propylene glycol and purified water to the sildenafil citrate powder, and form a smooth paste. Calculate the required quantity of each ingredient for the total amount to be prepared. Accurately weigh and/or measure each ingredient. Thoroughly pulverize the required number of sildenafil tablets for the prescription. (A high-speed mill/coffee grinder works well.) Add the propylene glycol and purified water to the sildenafil citrate powder, and form a smooth paste. Incorporate into sufficient hydrophilic ointment (Dermabase, Vanicream) to final weight and mix well. Warm the purified water to about 70°C and add to the powder-propylene glycol mixture. Package in tight, light-resistant containers.1 A beyond-use date of 14 days can be used for this preparation when stored in a refrigerator.1 Sildenafil cream and sildenafil gel have been used to improve uterine artery flow and endometrial development in patients undergoing in vitro fertilization. Study design:~This is a prospective self-controlled clinical trial.~Study subjects:~Investigators counseled and recruited 42 infertile women who had been diagnosed with anovulatory infertility, with normal baseline FSH, LH, and free testosterone levels, patent tubes on hysterosalpingography, and normal male semen analysis.~By the time they were enrolled in the study, all women had already completed 5 ovulatory cycles of Clomiphene citrate induction (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days) but without conception (clomiphene citrate failure) with thin endometrium (\<8mm) in at least 3 cycles. Ovulation was documented sonographically, and with day-21 serum progesterone exceeding 5 ng/ ml in all cases.~Exclusion criteria:~Women with major medical problems, male factor infertility, endocrine abnormalities such as hyperprolactinemia or abnormal thyroid functions, prior ovarian or adnexal surgery, or organic pelvic pathology were not included in the study.~Intervention:~Sixth cycle (Clomiphene citrate only):~Enrolled cases were asked to continue with Clomiphene citrate induction ( at the same dose) for the 6th cycle.

Year	Estimated Market Size (USD)	Growth Rate	Key Factors Influencing Growth
2023	150 million	8%	Rising prevalence of erectile dysfunction
2024	162 million	8%	Increased acceptance of topical applications
2025	175 million	8%	Advances in transdermal drug delivery technology
2026	190 million	8.5%	Expansion into emerging markets

A gel base, without medicament (vehicle only), was applied vaginally in a dose of 5 gm twice per day, from cycle day 8 to the day of HCG administration ( when follicular diameter reached 18 mm).