Stimate

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

Treatment

9 FDA approvals

20 Active Studies for Stimate

What is Stimate

Norgestimate

The Generic name of this drug

Treatment Summary

Norgestimate is a medication used in combination with ethinylestradiol to form an oral contraceptive that was developed in 1977. This combined contraceptive can also be used to treat moderate acne. Norgestimate was officially approved by the FDA in December 1989.

Ortho Tri Cyclen

is the brand name

Stimate 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 Stimate Affects Patients

Norgestimate is a contraceptive and acne treatment as it stops ovulation and reduces the amount of testosterone in the body. It is considered to be a safe drug, but patients should be aware of the potential risks such as vascular and liver disease, high blood pressure, changes in metabolism, headaches, and irregular bleeding.

How Stimate works in the body

Norgestimate, a type of progesterone hormone, works by decreasing the amount of hormone released by the brain that stimulates ovulation and testosterone production. This decrease in hormone levels reduces the amount of testosterone available in the body, which in turn helps to reduce symptoms of acne.

When to interrupt dosage

The recommended amount of Stimate relies on the diagnosed condition, including Hypermenorrhea, Postmenopausal Osteoporosis and Menstrual Distress (Dysmenorrhea). The measure of dosage depends on the mode of administration (e.g. Kit or Kit - Oral) as indicated in the table below.

Condition

Dosage

Administration

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

Oral Contraceptives

, 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

Stimate has eleven proscribed contraindications and must not be utilized when experiencing any of the conditions given in the following table.

Stimate 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 Stimate.

Common Stimate 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.

Stimate Toxicity & Overdose Risk

Overdosing on norgestimate is rare, but those who do may require symptomatic and supportive care. Most people who overdose on oral contraceptives do not experience serious harm.

Stimate Novel Uses: Which Conditions Have a Clinical Trial Featuring Stimate?

30 active trials are being conducted to examine the potential of Stimate in treating Postmenopausal Osteoporosis, moderate Vulvovaginal atrophy and Menopausal symptoms.

Condition

Clinical Trials

Trial Phases

Dysmenorrhea

1 Actively Recruiting

Not Applicable

Acne Vulgaris

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Oral Contraceptives

1 Actively Recruiting

Not Applicable

Menopause

0 Actively Recruiting

Polycystic Ovarian Syndrome

7 Actively Recruiting

Not Applicable, Phase 1

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Hirsutism

0 Actively Recruiting

Hot flashes

19 Actively Recruiting

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

moderate Vulvovaginal atrophy

0 Actively Recruiting

Menorrhagia

3 Actively Recruiting

Phase 1, Phase 2, Not Applicable

severe menopausal vulvovaginal atrophy

0 Actively Recruiting

Stimate Reviews: What are patients saying about Stimate?

4.3

Patient Review

5/1/2017

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

I've been using this for a while now, and it's been great...until recently. I started to experience some adverse side effects like headaches, flushing, and feeling nauseous after taking it. It honestly feels like I have the flu for a few days afterwards. I'm glad there's something out there to help with my bleeding, but I don't think I'll be using this as often as before due to how terrible I feel after taking it.

4.3

Patient Review

7/28/2014

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

Whenever I take Stimate Nasal Spray, I get a flushed face and laugh at everything. They noticed this in the hospital when they were testing how well Stimate would work with me and told me that it's normal to get "giddy." Now I have dentist's that think I'm high on weed when I go in to get a filling or when I got my wisdom teeth extracted. Other than the dentist's, this thing has worked great for me.

4.3

Patient Review

3/16/2008

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

I have had some negative side effects from using this medication, including feeling ill for a few days afterwards. My blood pressure goes up, I can't sleep, and I become very restless and agitated. However, it is effective in numbing me prior to dental work or surgery.

4

Patient Review

10/8/2012

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

My daughter has von Willebrand's disease, and this medication has been working great for her. She's able to take it without any problems, and it's much easier than the previous medication she was taking (which she wouldn't take because she couldn't stand the taste/texture).

4

Patient Review

3/20/2010

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

I unfortunately experience some negative side-effects, like a headache and general malaise, but it is otherwise an excellent medication.

4

Patient Review

9/8/2008

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

We use this medication frequently for my son's severe nosebleeds. So far, it seems to be working well.

3.7

Patient Review

1/22/2011

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

Though this medication is effective, the side effects are very unpleasant. I often felt nauseous, dizzy, and had headaches. Additionally, hot flashes and increased bleeding were common. To be honest, I would always try to avoid taking it if possible.

3.7

Patient Review

11/11/2010

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

I had a really severe reaction to this drug after my c-section. My sodium levels dropped dangerously low and I was unresponsive for over a day. I ended up in the ICU with brain swelling. If you take this, make sure they closely monitor your sodium levels.

3

Patient Review

9/28/2009

Stimate for Blood Clotting Disorder - Von Willebrand's Disease

Though this medication effectively controls my bleeding, the side-effects are incredibly severe. I once had to go to the hospital because of the vomiting it caused.

Patient Q&A Section about stimate

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

Is there a generic for Stimate?

"The prescription drug Stimate is not currently available in a generic form in the United States."

Answered by AI

Why was Stimate discontinued?

"Ferring Pharmaceuticals has issued a recall of the Stimate (desmopressin) nasal spray due to it containing higher amounts of desmopressin than specified. Stimate is used to treat von Willebrand disease (VWD) and mild hemophilia A."

Answered by AI

Is Stimate still available?

"The product is available in 31 states and can be purchased from STAQ by any pharmacy. NHF, HFA, and the Hemophilia Alliance are working with STAQ to get the product licensed in all 50 states."

Answered by AI

Clinical Trials for Stimate

Image of VA Greater Los Angeles Healthcare System, West Los Angeles, CA in West Los Angeles, United States.

EBQI Strategies for Women's Health

Any Age
All Sexes
West Los Angeles, CA

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

Waitlist Available
Has No Placebo

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Erin P Finley, PhD MPH

Image of Lindus Health - DECENTRALIZED STUDY in Boston, United States.

Neurostimulation for Heavy Menstrual Bleeding

14 - 45
Female
Boston, MA

The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria). During the first two consecutive menstrual cycles (M1 - M2, "Baseline Phase"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort. During the following three consecutive menstruations (M3 - M5, "Treatment Phase"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.

Waitlist Available
Online Trial

Lindus Health - DECENTRALIZED STUDY

Navid Khodaparast, PhD

Spark Biomedical, Inc.

Image of Goldring Center for High Performance Sport in Toronto, Canada.

Menstrual Cycle vs. Birth Control Pills for Protein Metabolism

18 - 40
Female
Toronto, Canada

The muscles of the body are constantly breaking down old proteins and building new ones. These two processes, protein breakdown and protein synthesis, together are known as protein turnover. Protein turnover is essential for maintaining healthy muscle. Despite its importance, females have historically been underrepresented in protein metabolism research. A long-standing assumption has been that fluctuations in female sex hormones such as estrogen and progesterone, whether across the natural menstrual cycle or in individuals using oral contraceptives (OCs), make metabolism and training responses too variable to study. Because of this, many researchers have excluded female participants for logistical reasons. Resistance exercise, such as weightlifting, is the most effective way to increase muscle size and strength. Each resistance-training session triggers muscle protein synthesis (MPS), the process by which new muscle proteins are built. Consuming dietary protein or individual amino acids further increases the rate at which new proteins are formed. Over time, higher rates of protein synthesis support muscle growth and the maintenance of other lean tissues in the body. The purpose of this study is to examine how menstrual cycle phases and OC use influence the synthesis of proteins in both muscle tissue and the rest of the body. Improving scientific understanding in this area will support more effective, evidence-based training and nutrition recommendations for females.

Recruiting
Has No Placebo

Goldring Center for High Performance Sport

Image of Erevna Innovations Inc. in Montreal, Canada.

Sculptra + Restylane for Post-Menopausal Skin Concerns

40 - 65
Female
Montreal, Canada

The post-menopausal state is marked by a sharp decline in estrogen, leading to significant structural and functional changes in the skin, including collagen loss, dryness, thinning, and reduced elasticity. To address these concerns, aesthetic injectables products such as Sculptra® Aesthetic (poly-L-lactic-acid \[PLLA- SCA\]) and Restylane Skinboosters®\[HASBV\] (small-particle hyaluronic acid - SP-HA) can be used. PLLA-SCA stimulates collagen production via cellular activation (biostimulator), gradually improving dermal structure. HASBV enhances hydration, elasticity, and skin texture when injected under the skin. Considering that hydration and laxity represent the primary aesthetic concerns in this patient population. Targeted treatment with SP-HA (HASBV) to improve hydration and PLLA-SCA to address laxity have been shown to produce significant clinical outcomes by directly addressing these key dermal deficiencies. This approach forms the basis of the current study.

Phase 4
Recruiting

Erevna Innovations Inc.

Andreas Nikolis, MD, PhD

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Image of Center for Human Nutrition in Fayetteville, United States.

Protein Meals for Polycystic Ovary Syndrome

18 - 50
Female
Fayetteville, AR

Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance, hyperandrogenism, and reproductive dysfunction. Dietary strategies that improve postprandial insulin and glucose responses are central to managing metabolic symptoms in PCOS. Meals higher in protein can attenuate postprandial glycemia and enhance satiety, but the effects may vary by protein source. Animal sources of protein typically have higher essential amino acid content and insulinogenic potential, whereas plant proteins offer fiber and phytochemicals that may influence glycemic dynamics differently. Few studies have directly compared the acute metabolic effects of plant versus animal protein in women with PCOS. Given the distinct pathophysiology of PCOS, extrapolating findings from healthy populations may be misleading. Understanding protein-specific effects on postprandial insulin, glucose, and appetite-regulating hormones in this group is essential for targeted nutrition guidance. Additionally, plant-based diets are increasingly promoted for cardiometabolic health, but their acute effects in insulin-resistant women remain underexplored. This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary recommendations aimed at improving metabolic outcomes in this high-risk population.

Recruiting
Has No Placebo

Center for Human Nutrition

Jamie I Baum, PhD

Image of William J. Hybl Sports Medicine and Performance Center in Colorado Springs, United States.

Moderate Aerobic Exercise for Menstrual Symptoms

18 - 40
Female
Colorado Springs, CO

The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.

Recruiting
Has No Placebo

William J. Hybl Sports Medicine and Performance Center

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Image of Noll Laboratory in University Park, United States.

Estradiol and Elagolix for Menopause

42 - 64
Female
University Park, PA

The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

Phase 4
Recruiting

Noll Laboratory

W. Larry Kenney, Ph.D.

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We made a collection of clinical trials featuring Stimate, we think they might fit your search criteria.
Go to Trials