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Angelica Benitez

Created on November 19, 2024

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Transcript

What is the estradiol concentration compared to baseline of 4mcg?

15 vs 8 pg/ml

no change

4.3 vs 3.9 pg/ml

What are the indications

Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

Treatment of moderate to severe dyspaerunia due to posmenopause

Treatment of severe dyspareunia

Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and FSH, through a negative feedback mechanism

The insert comes in contact with the vaginal mucosa, estradiol is released into the vagina.

What drug class and MOA

Estrogens act to reduce the elevated levels of LH hormones seen in postmenopausal women

How is IMVEXXY administered

1 vaginal insert daily for 2 weeks, followed by 1 insert twice weekly.

1 vaginal insert daily for 2 weeks

1 vaginal insert daily for 1 weeks.

How is product stored

Store at 72°F to 86ºF

Store at 28°C to 30ºC

Store at 20°C to 25ºC (68°F to 77ºF)

Which one of these are included in boxed warning?

ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA

HEADACHE, DEMENTIA,NAUSEA

NO BOX WARNING.

The most common adverse reaction with IMVEXXY (incidence ≥ 3% and greater than placebo)

HEADACHE

VAGINAL DISCHARGE

CARDIOVASCULAR EVENTS

Which dose has an LS change from baseline as -1.52

10mcg

1mg

4mcg

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Share your idea with an image

If you want to provide additional information or develop the content in more detail, you can do so through your oral presentation. We recommend that you practice your voice and rehearse: the best improvisation is always the most prepared!

Share your idea with an image

If you want to provide additional information or develop the content in more detail, you can do so through your oral presentation. We recommend that you practice your voice and rehearse: the best improvisation is always the most prepared!

Share your idea with an image

If you want to provide additional information or develop the content in more detail, you can do so through your oral presentation. We recommend that you practice your voice and rehearse: the best improvisation is always the most prepared!

Share your idea with an image

If you want to provide additional information or develop the content in more detail, you can do so through your oral presentation. We recommend that you practice your voice and rehearse: the best improvisation is always the most prepared!

Share your idea with an image

If you want to provide additional information or develop the content in more detail, you can do so through your oral presentation. We recommend that you practice your voice and rehearse: the best improvisation is always the most prepared!

Share your idea with an image

If you want to provide additional information or develop the content in more detail, you can do so through your oral presentation. We recommend that you practice your voice and rehearse: the best improvisation is always the most prepared!

Share your idea with an image

If you want to provide additional information or develop the content in more detail, you can do so through your oral presentation. We recommend that you practice your voice and rehearse: the best improvisation is always the most prepared!