Norgestimate And Ethinyl Estradiol

Acne Vulgaris, moderate Vulvovaginal atrophy, Hot flashes + 9 more

Treatment

9 FDA approvals

20 Active Studies for Norgestimate And Ethinyl Estradiol

What is Norgestimate And Ethinyl Estradiol

Norgestimate

The Generic name of this drug

Treatment Summary

Ethinylestradiol is a synthetic form of the female hormone estrogen used in many oral contraceptive pills. It was first developed in 1938 by Hans Herloff Inhoffen and Walter Hohlweg at Schering, and was approved by the FDA in 1943. It is more effective than other forms of estrogen due to its higher oral bioavailability, meaning that it can be taken in pill form instead of being injected.

Ortho Tri Cyclen

is the brand name

image of different drug pills on a surface

Norgestimate And Ethinyl Estradiol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Ortho Tri Cyclen

Norgestimate

1989

113

Approved as Treatment by the FDA

Norgestimate, commonly known as Ortho Tri Cyclen, is approved by the FDA for 9 uses which include Postmenopausal Osteoporosis and severe menopausal vulvovaginal atrophy .

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

severe menopausal vulvovaginal atrophy

Used to treat severe menopausal vulvovaginal atrophy in combination with Estradiol

Oral Contraceptives

Used to treat Oral Contraceptives in combination with Ethinylestradiol

Acne Vulgaris

Used to treat moderate Acne vulgaris in combination with Ethinylestradiol

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

moderate Vulvovaginal atrophy

Used to treat moderate Vulvovaginal atrophy in combination with Estradiol

Hot flashes

Used to treat Menopause in combination with Estradiol

moderate Menopausal Vasomotor Symptoms

Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol

Menopause

Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol

Effectiveness

How Norgestimate And Ethinyl Estradiol Affects Patients

Ethinylestradiol is a man-made form of estrogen that is taken once daily. It works by reducing the hormones that cause ovulation and endometrial vascularization. It is considered to be a safe drug, but there is a risk of blood clots associated with it, so individuals taking it should be aware of the potential risks.

How Norgestimate And Ethinyl Estradiol works in the body

Ethinylestradiol is a synthetic form of the hormone estrogen. It works by preventing ovulation and making it harder for sperm to reach the uterus. It also reduces luteinizing hormone and increases sex hormone binding globulin, which reduces the amount of estrogen in the body. This can lead to decreased bone density.

When to interrupt dosage

The advocated measure of Norgestimate and Ethinyl Estradiol is contingent upon the diagnosed condition, such as Acne Vulgaris, Hormonal Contraception and Folate supplementation therapy. The quantity of dosage fluctuates, in accordance with the technique of delivery indicated in the accompanying table.

Condition

Dosage

Administration

Oral Contraceptives

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Polycystic Ovarian Syndrome

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

moderate Vulvovaginal atrophy

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

severe menopausal vulvovaginal atrophy

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Menopause

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Osteoporosis, Postmenopausal

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Menorrhagia

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Hirsutism

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

moderate Menopausal Vasomotor Symptoms

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Hot flashes

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Acne Vulgaris

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Dysmenorrhea

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

Warnings

Norgestimate And Ethinyl Estradiol Contraindications

Condition

Risk Level

Notes

Breast

Do Not Combine

Breast Cancer

Do Not Combine

high risk of arterial thrombotic disease

Do Not Combine

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Hypersensitivity

Do Not Combine

Venous Thrombosis

Do Not Combine

Pulse Frequency

Do Not Combine

estrogen-sensitive cancer

Do Not Combine

Metrorrhagia

Do Not Combine

Liver Neoplasms

Do Not Combine

There are 20 known major drug interactions with Norgestimate And Ethinyl Estradiol.

Common Norgestimate And Ethinyl Estradiol Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Norgestimate.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Norgestimate.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Norgestimate.

Aminophylline

Major

The metabolism of Aminophylline can be increased when combined with Norgestimate.

Astemizole

Major

The metabolism of Astemizole can be increased when combined with Norgestimate.

Norgestimate And Ethinyl Estradiol Toxicity & Overdose Risk

Women who overdose on this medication may suffer from bleeding, nausea, vomiting, breast pain, abdominal pain, drowsiness, and fatigue. Treatment should include supportive care such as monitoring for potassium and sodium levels, as well as signs of metabolic acidosis.

image of a doctor in a lab doing drug, clinical research

Norgestimate And Ethinyl Estradiol Novel Uses: Which Conditions Have a Clinical Trial Featuring Norgestimate And Ethinyl Estradiol?

38 active clinical studies are exploring the potential of Norgestimate and Ethinyl Estradiol in providing Folate supplementation therapy, relieving Premenstrual Dysphoric Disorder and treating Menopause.

Condition

Clinical Trials

Trial Phases

Dysmenorrhea

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Oral Contraceptives

0 Actively Recruiting

Menopause

0 Actively Recruiting

Polycystic Ovarian Syndrome

9 Actively Recruiting

Phase 1, Not Applicable

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Hirsutism

0 Actively Recruiting

Hot flashes

30 Actively Recruiting

Not Applicable, Phase 2, Phase 4, Early Phase 1, Phase 3, Phase 1

moderate Vulvovaginal atrophy

0 Actively Recruiting

Menorrhagia

0 Actively Recruiting

severe menopausal vulvovaginal atrophy

0 Actively Recruiting

Norgestimate And Ethinyl Estradiol Reviews: What are patients saying about Norgestimate And Ethinyl Estradiol?

5

Patient Review

7/12/2016

Norgestimate And Ethinyl Estradiol for Acne

I'm really happy with this birth control. I started using it when I was 23 and had never dealt with acne before, but then I suddenly got it really bad. After just five months of use, my face cleared up and has stayed that way ever since.

5

Patient Review

4/6/2017

Norgestimate And Ethinyl Estradiol for Birth Control

I had extremely negative experiences with my last birth control pill in terms of mental health, so I was really relieved to find that this one didn't have the same issue! It's also been great in clearing up my acne and making my periods shorter. The only downside is that I experienced some spotting when I first started taking them, but that's par for the course with any BC pill. All things considered, I'm very happy with this form of contraception.

5

Patient Review

12/4/2016

Norgestimate And Ethinyl Estradiol for Birth Control

It took me a long time to find the right birth control, but this one has really worked well for me. I would urge other women who are struggling to find something that works for them to keep trying different options and not give up hope.

5

Patient Review

2/24/2022

Norgestimate And Ethinyl Estradiol for Abnormal Bleeding from the Uterus

I have found that this treatment provides me with energy and no negative side effects like headaches or cramps.

4.3

Patient Review

3/8/2018

Norgestimate And Ethinyl Estradiol for Birth Control

I've been using this birth control for a little over a year and it's been effective. However, one downside is that it's caused me to break out on my face occasionally and also has resulted in melasma.

3.7

Patient Review

1/24/2018

Norgestimate And Ethinyl Estradiol for Birth Control

I had such bad cystic acne after Nexplanon that my doctor recommended I try Starylla. Unfortunately, this didn't work out too well for me. After just two days of taking the pills (as directed, before bed), I woke up in the middle of the night with nausea and ended up vomiting both nights. I also had a headache and felt dizzy all day long.

2.7

Patient Review

3/17/2021

Norgestimate And Ethinyl Estradiol for Abnormally Long or Heavy Periods

I started using this treatment last month and have had really heavy periods with bad cramps. It's like I'm not even on birth control! I'll try for the next two months and see if there are any changes, but I'm worried about the possible side effect of blood clots.

2

Patient Review

5/3/2016

Norgestimate And Ethinyl Estradiol for Premenstrual Disorder with a State of Unhappiness

It's been three months and I've been taking BC to treat my PMS symptoms. The first month was really tough with nausea and vomiting, but that has passed. Now I'm just dealing with some weight gain, acne, and bleeding between periods. I'm hoping everything will be alright after the third month.

2

Patient Review

6/4/2017

Norgestimate And Ethinyl Estradiol for Birth Control

I started taking this medication a few months ago and have already experienced some bad side effects. For example, I've had a continuous period for three weeks now, with no break in between cycles. Additionally, I often feel nauseous and have been getting blurred vision and migraines more frequently. I never had such problems when taking Ortho Tri Cyclen.

1.7

Patient Review

1/22/2019

Norgestimate And Ethinyl Estradiol for Abnormally Long or Heavy Periods

I started this medication in order to help with my periods and cysts, but it's only made things worse. I've been moody, crying, vomiting, and in the second month of taking it I started a period that hasn't gone away yet. And on top of all that, I had a yeast infection the first month. They say you should give it three months to work, but I'm already miserable.

1.7

Patient Review

12/3/2018

Norgestimate And Ethinyl Estradiol for Birth Control

I am a healthy 25 year old and began taking the pill again after giving my body a break from birth control. I am experiencing extremely bad mood swings very often and crying more than I ever have before. This definitely is not like me and I am going to stop taking this immediately.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about norgestimate and ethinyl estradiol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is norgestimate and ethinyl estradiol a good birth control?

"Norgestimate and ethinyl estradiol birth control pills have a high success rate of over 99 percent when used correctly, and are still 91 percent effective in everyday use."

Answered by AI

What is the side effects of norgestimate ethinyl estradiol?

"The following side effects may occur: nausea, vomiting, headache, bloating, breast tenderness, swelling of ankles/feet (fluid retention), or weight change. Spotting (vaginal bleeding between periods) or missed/irregular periods may occur, especially during the first few months of use."

Answered by AI

What kind of birth control is norgestimate and ethinyl estradiol?

"This medication prevents ovulation and pregnancy by combining the hormones estrogen and progestin. It may also be used to treat acne."

Answered by AI

Do you get a period on norgestimate?

"As your body adjusts to this method of contraception, the bleeding should become less and eventually stop. If breakthrough bleeding continues off-and-on for more than 1 week or occurs after your period, call your healthcare professional.

When you first start using this contraception method, you may experience vaginal bleeding of various amounts between your regular menstrual periods. This is sometimes called spotting when it is light, or breakthrough bleeding when it is heavier. If this should occur, continue with your regular dosing schedule. As your body adjusts to this method of contraception, the bleeding should become less and eventually stop. If breakthrough bleeding continues off-and-on for more than 1 week or occurs after your period, call your healthcare professional."

Answered by AI

Clinical Trials for Norgestimate And Ethinyl Estradiol

Image of Citruslabs in Las Vegas, United States.

Primal Meno+ Supplement for Menopause

40 - 60
Female
Las Vegas, NV

This study evaluates the effects of Primal Harvest's Primal Meno+ supplement on symptoms of menopause and overall well-being in females aged 40-60 who are currently menopausal and experiencing at least two menopausal symptoms. Over a 12-week period, 40 participants will take one capsule of the test product daily with their first meal of the day. Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess menopausal symptoms (including hot flashes, night sweats, sleep quality, stress resilience, and emotional well-being) and overall health and well-being. This is a single-arm, open-label, virtual trial with no randomization or blinding.

Waitlist Available
Has No Placebo

Citruslabs

Primal Harvest, LLC

Image of St. Joseph's Healthcare Hamilton in Hamilton, Canada.

Internet-Delivered Cognitive Behavioural Therapy for Hot Flashes

40 - 60
Female
Hamilton, Canada

Given the impact that hot flashes and night sweats can have on daily life during the menopausal transition, our team has developed a therapist-guided online cognitive behavioural therapy (CBT)- based program to help individuals manage these symptoms. An online program may help address systemic barriers to in-person care, such as cost, time, travel, and caregiving needs. The broad aim of this pilot clinical trial is to examine the experience of a four-week therapist-guided online CBT-based program for menopause-related hot flashes and night sweats. The primary objective of this study is to evaluate the acceptability and feasibility of the four-week online program, including how participants experience the program and how well they are able to complete it at home. The secondary objective is to explore whether the program may help with hot flashes and night sweats, and related concerns such as sleep, mood, anxiety, and quality of life. Exploratory analyses will examine whether changes in these outcomes are maintained three months after completing the program. Researchers will compare participants who receive the program immediately with participants who wait four weeks before receiving it. Participants will: * Complete online questionnaires about their symptoms and well-being. * Complete four weekly online lessons and activities. * Meet briefly with a guide each week for guidance and support. * Complete follow-up questionnaires after the program and three months later.

Waitlist Available
Has No Placebo

St. Joseph's Healthcare Hamilton

Sheryl M Green, PhD, CPsych

Image of MusB Research LLC in New Port Richey, United States.

Ashoka Bark and Shatavari for Menopause

40 - 65
Female
New Port Richey, FL

This 12-week randomized, placebo-controlled clinical trial will evaluate the efficacy and safety of a daily oral supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms. Up to 50 participants will be randomized to receive either the active supplement or placebo, with 40 participants expected to complete the study. Participants will attend visits at Weeks 0, 6, and 12, where hormone levels (FSH and estradiol), menopausal symptoms, quality of life, anxiety, cognitive function, and sleep will be assessed using validated measures. The study will also explore changes in the vaginal microbiome and monitor safety and adherence throughout the trial. The study will be conducted at MusB Research in New Port Richey, Florida.

Recruiting
Dietary Supplement

MusB Research LLC

Vidya USA Corporation

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Estradiol/Levonorgestrel Patch for Menopause

40 - 75
Female
Las Vegas, NV

The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS. The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products. The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.

Phase 1
Recruiting

Novum Pharmaceutical Research Services

Corium Innovations, Inc.

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Hormonal Effects on Brain Stimulation for Depression

18 - 40
All Sexes
Pittsburgh, PA

This study is investigating how two types of non-invasive brain stimulation, transcranial electrical stimulation (TES) and transcranial magnetic stimulation (TMS), affect brain activity, and whether combining them produces stronger or more consistent effects than either one used alone. The motivation for this comes from the observation that TMS, which is FDA-approved for treating depression, tends to work less well in postmenopausal women because lower estrogen levels reduce the brain's ability to respond to stimulation. The research team believes that pairing TMS with TES, which targets a different set of brain cells, may be able to overcome this hormonal barrier and make stimulation more effective. Participants will come into the lab for up to 24 visits over 8 months, beginning with an initial visit to establish the right stimulation settings, followed by a series of stimulation sessions in which brain activity is measured before and after receiving either TES, TMS, or both together. For female participants, sessions will be scheduled at specific points in the menstrual cycle to capture the natural monthly rise and fall of estrogen, while male participants will be scheduled on a comparable fixed interval as a comparison group. The insights gained from this study could directly inform the development of better, more reliable brain stimulation treatments for women with depression.

Waitlist Available
Has No Placebo

Carnegie Mellon University

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