Ortho-Cept

Birth Control, Acne Vulgaris, Folate supplementation therapy + 5 more

Treatment

1 FDA approval

20 Active Studies for Ortho-Cept

What is Ortho-Cept

Ethinylestradiol

The Generic name of this drug

Treatment Summary

Ethinylestradiol is an estrogen-based drug first developed in 1938 by Hans Herloff Inhoffen and Walter Hohlweg at Schering. The drug was designed to have a higher bioavailability when taken orally than other estrogens. Ethinylestradiol is primarily used in birth control pills and was approved by the FDA in 1943.

LOESTRIN Fe 1.5/30

is the brand name

image of different drug pills on a surface

Ortho-Cept Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

LOESTRIN Fe 1.5/30

Ethinylestradiol

1973

679

Approved as Treatment by the FDA

Ethinylestradiol, also known as LOESTRIN Fe 1.5/30, is approved by the FDA for 1 uses including Birth Control .

Birth Control

Used to treat Contraception in combination with Levonorgestrel

Effectiveness

How Ortho-Cept Affects Patients

Ethinylestradiol is a synthetic form of estrogen used to prevent ovulation. Patients take it once a day and usually don't experience serious side effects if they take too much. However, they should be aware that it can increase their risk of thrombotic events.

How Ortho-Cept works in the body

Ethinylestradiol is a synthetic hormone used in some birth control pills. It works to reduce ovulation and make it harder for sperm to reach an egg. It also thickens cervical mucus, which prevents sperm from entering the uterus. Ethinylestradiol can also reduce bone density and reduce the hormones that cause the uterus to get ready for a fertilized egg. It also increases the amount of a protein that helps bind hormones in the body.

When to interrupt dosage

The amount of Ortho-Cept is contingent upon the determined condition, such as Acne Vulgaris, Hormonal Contraception and Folate supplementation therapy. The measure of dosage can be sourced in the table beneath, based on the technique of delivery.

Condition

Dosage

Administration

Birth Control

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Folate supplementation therapy

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Hormonal Contraception

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Menopause

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Acne Vulgaris

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Patient desires oral contraception for birth control

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Acne Vulgaris

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Osteoporosis

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Warnings

Ortho-Cept has twenty-six counterindications, so it should not be used when encountering any of the conditions listed in the following table.

Ortho-Cept Contraindications

Condition

Risk Level

Notes

Smoking

Do Not Combine

Metrorrhagia

Do Not Combine

estrogen-sensitive cancer

Do Not Combine

Thrombophlebitis

Do Not Combine

Venous Thrombosis

Do Not Combine

Venous Thrombosis

Do Not Combine

Pulse Frequency

Do Not Combine

Breast

Do Not Combine

Coronary Artery Disease

Do Not Combine

high risk of arterial thrombotic disease

Do Not Combine

Thromboembolism

Do Not Combine

Coronary Disease

Do Not Combine

Hypersensitivity

Do Not Combine

Pulse Frequency

Do Not Combine

Adrenal Insufficiency

Do Not Combine

major surgery with prolonged immobilization

Do Not Combine

Pulse Frequency

Do Not Combine

Hypertension

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Breast Cancer

Do Not Combine

Liver Neoplasms

Do Not Combine

Deep Vein Thrombosis

Do Not Combine

Fibrosis

Do Not Combine

Breast

Do Not Combine

Renal Insufficiency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Ethinylestradiol may interact with Pulse Frequency

There are 20 known major drug interactions with Ortho-Cept.

Common Ortho-Cept Drug Interactions

Drug Name

Risk Level

Description

Anastrozole

Major

The therapeutic efficacy of Anastrozole can be decreased when used in combination with Ethinylestradiol.

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Ethinylestradiol.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Ethinylestradiol.

Belinostat

Major

The metabolism of Belinostat can be increased when combined with Ethinylestradiol.

Binimetinib

Major

The metabolism of Binimetinib can be increased when combined with Ethinylestradiol.

Ortho-Cept Toxicity & Overdose Risk

Women who overdose on this drug may experience bleeding, nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and fatigue. Treatment should include supportive care, such as monitoring potassium and sodium levels and looking for signs of acidosis.

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

Ortho-Cept Novel Uses: Which Conditions Have a Clinical Trial Featuring Ortho-Cept?

Currently, 38 active studies are investigating the potential of Ortho-Cept to provide Folate supplementation therapy, ameliorate Premenstrual Dysphoric Disorder and Menopause symptoms.

Condition

Clinical Trials

Trial Phases

Birth Control

21 Actively Recruiting

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

Hormonal Contraception

0 Actively Recruiting

Folate supplementation therapy

0 Actively Recruiting

Patient desires oral contraception for birth control

0 Actively Recruiting

Osteoporosis

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Menopause

0 Actively Recruiting

Ortho-Cept Reviews: What are patients saying about Ortho-Cept?

5

Patient Review

8/15/2008

Ortho-Cept for Birth Control

I've been on this medication for 16 years now and it's been great! I've had no problems with it, except for some recent spotting. My doctor just switched me to something else. This is the only pill that hasn't made me sick to my stomach.

5

Patient Review

7/6/2016

Ortho-Cept for Acne

I was very pleased with this medication, though the first few weeks were a bit difficult. I experienced some nausea and cramping, but nothing too severe. My acne cleared up completely, which was a huge plus, and I didn't experience any negative side effects after several months of use.

4.3

Patient Review

1/9/2013

Ortho-Cept for Birth Control

I've been using this medication for four months with great results, but I've noticed a change in my period recently. Where before it was very heavy and would last a week, now it's light and only lasts a couple days. Cramp pain is gone and have had no side effects yet, I also lost a few pounds which was great!

4.3

Patient Review

2/27/2012

Ortho-Cept for Birth Control

I'm really happy with this birth control. I had a few issues the first week, but no side effects that I've experienced so far.

4

Patient Review

3/24/2009

Ortho-Cept for Birth Control

I'm pleased with the results of this medication, but I am curious about whether or not it will interfere with my menstrual cycle.

3.7

Patient Review

4/29/2014

Ortho-Cept for Birth Control

I found this treatment to be very ineffective. Not only did it do nothing to help my depression, but it also made me gain weight and lose interest in sex. The only positive effect I experienced was that it lightened the texture of my facial and body hair.

3.7

Patient Review

1/18/2009

Ortho-Cept for Birth Control

While taking this medication, my blood pressure rose to an unhealthy level and I had to discontinue use.

3.3

Patient Review

11/3/2009

Ortho-Cept for Birth Control

I had some negative side effects when I first started taking this medication, including dizziness and migraines. Those went away for a little while but have since returned. I've also been experiencing stomach pain, weight gain, and loss of libido. I'm going to talk to my doctor about it tomorrow and see what they say.

3

Patient Review

11/17/2007

Ortho-Cept for Disease of Ovaries with Cysts

I had good results with this medication in terms of my initial symptoms, but then I began having rare side effects like severe migraines and stomach pains. Additionally, I started feeling depressed and having suicidal thoughts. So, obviously, I stopped taking the medication and haven't gone back since. When I told my doctor about what happened, they said they were surprised but not shocked to hear it; apparently, this is a relatively common side effect of the drug.

1.7

Patient Review

2/16/2010

Ortho-Cept for Birth Control

I was really disappointed with this product. I spotted for an entire month within the first month of use, and then experienced a significant dip in my mood and motivation levels. Sex was no longer enjoyable.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about ortho-cept

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

Why was Ortho-Cept discontinued?

"Ortho-Cept, a birth control pill, is being recalled due to the potential for it to have low potency."

Answered by AI

Is Ortho-Cept discontinued?

"The Ortho-Cept brand name has been stopped in the U.S. If cheaper copies of this product have been approved by the FDA, there might be cheaper equivalents available."

Answered by AI

What is Ortho-Cept used for?

"This medication is a combination of two hormones, progestin and estrogen, which are used to prevent pregnancy. In addition to preventing pregnancy, birth control pills may also make your periods more regular, decrease blood loss and pain during periods, decrease your risk of ovarian cysts, and treat acne."

Answered by AI

What is the equivalent of Ortho-Cept?

"The FDA has declared that the following brands of oral contraceptives are safe and effective for emergency contraception: Ovral ® (1 dose is 2 white pills), Alesse ® (1 dose is 5 pink pills), Nordette ® or Levlen ® (1 dose is 4 yellow pills)."

Answered by AI

Clinical Trials for Ortho-Cept

Image of University of California, San Diego in La Jolla, United States.

Lidocaine for Pain Control in Birth Control

18 - 50
Female
La Jolla, CA

The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying participants opinions of their clinicians' empathy. The investigators are inviting patients who arrive at their clinic visit seeking an IUD. Usually, at University of California, San Diego (UCSD), for patients who have never delivered a baby, clinicians use a buffered paracervical block for before IUD placement. The purpose of this research study is to investigate whether a "buffered" (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block (numbing medication given on both sides of the cervix) is effective in reducing pain during IUD placement in individuals with prior C-sections, the difference between buffered and unbuffered for nulliparous patients, and whether a medicated gel reduces pain with the paracervical block.

Recruiting
Paid Trial

University of California, San Diego

Sheila K Mody, MD, MPH

Image of EmpoweRx, Inc in Del Mar, United States.

HAPPI Software for Birth Control Access

18+
All Sexes
Del Mar, CA

The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are: 1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy? 2. Does the HAPPI software make it easier for patients to access birth control? Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access. Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.

Recruiting
Has No Placebo

EmpoweRx, Inc

Image of Calabasas Pharmacy in Calabasas, United States.

Electronic Health Record Platform for Birth Control

18 - 51
Female
Calabasas, CA

Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider. Over the past decade, pharmacists have gained the authority to prescribe contraceptives in many states, allowing patients to access these medications directly in pharmacies without first seeing another healthcare provider. The Pharmacist Resource to Implement Services as Modules (PRISM) is an Electronic Health Record platform designed to streamline workflows and provide clinical decision support, making it easier and safer to deliver clinical services in community pharmacies. This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community pharmacies across the United States over a 12-week period. The study will assess the quality of care, contraception continuation and failure rates, side effect rates, preventative healthcare utilization, and overall patient experience with pharmacy contraceptive services.

Waitlist Available
Has No Placebo

Calabasas Pharmacy (+4 Sites)

OvaryIt, LLC

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Image of Jackson State University/Department of Behavioral & Environmental Health in Jackson, United States.

PEN-3 Intervention for Postpartum Depression

18 - 45
Female
Jackson, MS

Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.

Recruiting
Has No Placebo

Jackson State University/Department of Behavioral & Environmental Health

Mary Shaw, PhD

Image of University of Colorado Anschutz Medical Campus in Aurora, United States.

Birth Control Pills and DNA Interaction

18 - 45
Female
Aurora, CO

The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how individual bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. The investigators are also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are: * Do individuals with the CYP3A7\*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill? * Do individuals with the CYP3A7\*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill? * What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users? Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures: * Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill * Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill * Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill * A transvaginal ultrasound to measure any ovarian follicles (optional procedure)

Phase 4
Recruiting

University of Colorado Anschutz Medical Campus (+2 Sites)

Aaron M Lazorwitz, MD, PhD

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Image of Greater Boston Health Center in Boston, United States.

SBIRT for Alcohol and Substance Use Disorders

18+
All Sexes
Boston, MA

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Recruiting
Has No Placebo

Greater Boston Health Center (+3 Sites)

Kelli S Hall, MD

Image of OHSU in Portland, United States.

Progestin Contraceptives for Birth Control Effects

18 - 40
Female
Portland, OR

The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use. Participants will choose to receive the contraceptive implant (Etonogestrel implant also called Nexplanon) or the contraceptive injectable (Depo-medroxyprogesterone acetate (DMPA) also called Depo-Provera) for up to 12 months. They will be asked to have 4 endometrial biopsies over the course of the study, as well as blood draws, physical exams, and pregnancy tests. Participants will also use a daily text message or email diary to report bleeding patterns. This study's plan is to comprehensively phenotype bleeding patterns and profile the entire endometrium using single-cell RNA seq data (sCRNAseq).

Phase < 1
Recruiting

OHSU

Alison Edelman, MD

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