estradiol/norethindrone oral / Generic mfg. - LARVOL DELTA

Ovarian suppression using GnRH analog followed by estrogen and progestin for the classic form of lipoid congenital adrenal hyperplasia: A case report and its implications for ovarian morphology (ESPE-ESE 2025) - "After thorough discussions with her guardians, subcutaneous injections of leuprorelin acetate were initiated and maintained until the transition to estradiol and norethindrone at 14 years of age. These findings suggest that this therapeutic approach may prevent such ovarian complications in patients with the classic form of LCAH. Further clinical studies are warranted to evaluate the efficacy and safety of this intervention."

Case report • Clinical • Congenital Adrenal Hyperplasia • Endocrine Disorders • Nephrology • Renal Disease • Women's Health

Use of Oral Gonadotropin Releasing Hormone Antagonist Combinations for Preoperative Management of Refractory Leiomyoma-Related Heavy Menstrual Bleeding. (PubMed, Womens Health Rep (New Rochelle)) - "An alternative course of action is the use of oral GnRH antagonist combination therapy (OGAC) with estradiol and norethindrone, an option approved in both the United States and the European Union for long-term treatment of leiomyoma-related heavy menstrual bleeding. To demonstrate the clinical utility of OGAC therapy in the preoperative setting, we report a successful patient outcome and review relevant literature."

Journal • Gynecology • Hematological Disorders • Oncology • Solid Tumor • Uterine Leiomyoma

Melasma secondary to drugs: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS). (PubMed, BMC Pharmacol Toxicol) - "Melasma is associated with exposure to various medications, with a notable proportion of cases coincided with contraceptive use. The mechanisms involved include hormonal disturbances and oxidative stress."

Adverse events • Journal • Real-world evidence • Dermatology • Dermatopathology • Endocrine Disorders

A Novel Intrauterine Device for the Extended Tissue-Specific Release of Estradiol and Norethindrone to Treat the Genitourinary Syndrome of Menopause. (PubMed, Polymers (Basel)) - "Moreover, the MCDDS components showed good cytocompatibility against NIH/3T3 cells, with cell viability of more than 70%. Upon evaluation of the MCDDS system, the results of this study highlight its potential as a viable sustained-release intrauterine platform for the treatment of GSM."

Journal • Long-acting Reversible Contraceptives • Women's Health

Effectiveness and safety of hormone replacement therapy in the treatment of menopausal syndrome: a meta-analysis. (PubMed, Am J Transl Res) - "HRT can enhance the quality of life and vaginal health in women experiencing menopausal symptoms, elevate estrogen levels, and improve bone density, while demonstrating a favorable safety profile with no significant increase in adverse events or dyslipidemia risk. Further investigations involving multi-center, large-scale studies with long-term follow-up are warranted to substantiate this conclusion."

Journal • Retrospective data • Review • Dyslipidemia • Metabolic Disorders

Evaluation of the NuVera ICE Catheter during Percutaneous Procedures in which access to the left atrium is performed via transseptal puncture (ANZCTR) - P=N/A | N=25 | Withdrawn | Sponsor: NuVera Medical Inc. | Not yet recruiting ➔ Withdrawn

Trial withdrawal • Atrial Fibrillation • Cardiovascular

Ovulation Incidence in Oral Contraceptive Users (clinicaltrials.gov) - P3 | N=58 | Suspended | Sponsor: University of Southern California | Trial completion date: Jan 2024 ➔ Jan 2025

Trial completion date

Adequacy of Estradiol/Norethindrone Acetate to Mitigate Dose-Dependent and Progressive Decline in Bone Mineral Density Observed with Gonadotropin-Releasing Hormone Receptor Agonism/Antagonism (ACOG 2024) - P2, P3 | "Introduction: Bone mineral density (BMD) data from the relugolix monotherapy endometriosis program were used to investigate the impact of relugolix combination therapy (Relugolix-CT: relugolix 40mg, estradiol 1mg, norethindrone acetate 0.5mg) on bone loss. Progressive and dose-dependent declines in BMD were observed with relugolix monotherapy; changes were comparable at Week 12 and 24 between relugolix 40mg (–2.10% and –4.90%, respectively) and leuprorelin (–2.21% and –4.43%). In women treated with relugolix monotherapy for 12 weeks who transitioned to Relugolix-CT, there was a decline in BMD at Week 12 (–1.72%), followed by stabilization at Week 24 (–1.86%), with upward drift for the remainder of treatment (Week 104: –0.56%). Women treated continuously with Relugolix-CT demonstrated a BMD decrease of less than 1% from baseline at Week 24 (–0.92%), followed by stabilization by Week 36 (–0.66%) and plateau through Week 104 (–0.45%)."

Endometriosis • Gynecology • Osteoporosis • Women's Health

Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Xiao Wang

New trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Oral GnRH Antagonists in Combination with Estradiol and Norethindrone Acetate for Pain Relief Associated with Endometriosis: A Review of Evidence of a Novel Class of Hormonal Agents. (PubMed, Int J Womens Health) - "Around one third of patients are not responsive to oral contraceptives or progestins due to progesterone resistance...Oral GnRH antagonists, including elagolix, relugolix, and linzagolix allow oral administration, induce dose dependent reduction of estradiol levels, do not cause initial flare up of endometriosis symptoms, and allow the fast return of ovarian function and menstruation after discontinuation...Linzagolix, in a dose of 75 mg/day, can be used alone to treat endometriosis associated pain. For severe pelvic pain and dyspareunia, linzagolix can be used in a high dose of 200 mg/day with hormonal add-back therapy to preserve bone health."

Combination therapy • Journal • Review • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Oral Contraceptive (Ethinyl Estradiol and Norethindrone Acetate)-Induced Hepatic Adenomas: A Case Report (ASHP 2023) - No abstract available

Clinical • Gastrointestinal Cancer • Hepatocellular Cancer

A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Completed | N=30 ➔ 42

Enrollment change • Trial completion

Gender Affirming Hormone Therapy in a Non-Binary Individual with Swyer Syndrome (ENDO 2023) - "They had a bone mineral density scan two years prior to presentation that was reportedly normal.To avoid the deleterious effects of hypogonadism they were started on estradiol-norethindrone 0.05 - 0.25 mg patch to provide bone protection... Patient's with Swyer syndrome should be on appropriate hormone replacement as they do not make endogenous sex steroids. Additional consideration of masculinizing hormone replacement should be made for patients that have a gender identity other than cisgender female. It is also important to screen patients for gonadal tumors as there is an increased incidence in this population."

Clinical • Endocrine Disorders • Genetic Disorders • Germ Cell Tumors • Oncology • Osteoporosis • Turners Syndrome • Women's Health

Ovulation Incidence in Oral Contraceptive Users (clinicaltrials.gov) - P3 | N=58 | Suspended | Sponsor: University of Southern California | Trial completion date: Jan 2020 ➔ Jan 2024 | Unknown status ➔ Suspended | Trial primary completion date: Jan 2020 ➔ Jan 2024

Trial completion date • Trial primary completion date • Trial suspension

"Kliogest and Kliovance come in dial packs in Australia, but pink and blue respectively" (@DrDevora)

A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

Exogenous estrogen use for contraception and hormone replacement therapy and the risk of thrombosis in women with COVID-19 (ISTH 2022) - "HRT was defined as any treatment consisting of an estrogen analog with or without a progesterone...The most common estrogen therapies were norethindrone-estradiol (38%) and conjugated estrogen (14.1%)... 92 patients were identified who were diagnosed with COVID-19 while on hormone therapy at the time of diagnosis. 18 of the patients were hospitalized. Mean age was 42 years and 59 years for all patients and hospitalized patients, respectively."

Clinical • Cardiovascular • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Thrombosis • Venous Thromboembolism

"$HY Nuvera to Power Fuel Cell Electric Bus in Northeast India https://t.co/Xpy9L5nflB" (@otcdynamics)

A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion

".@novonordisk can you tell me if your kliovance pill plastic packaging is recyclable or not? Thanks." (@goezavin)

"NuVera 3D ICE in LA to image post device leak closure." (@aalahmadmd)

A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

The effect of low-dose combined hormone therapy (oestradiol and norethindrone acetate) on serum C-reactive protein levels and life quality in natural menopause women. (PubMed, Prz Menopauzalny) - "Considering all HT types and biochemical effects, low-dose HT, which had positive results in terms of quality of life, was a safe treatment and could be preferred to conventional-dose preparations in cases without contraindications. Low-dose combined HT containing oestradiol and norethindrone acetate did not alter the serum CRP level in postmenopausal cases."

Journal • CRP

Apoplectic leiomyomas: does ethnicity make a difference? a clinicopathologic study. (PubMed, Virchows Arch) - "Women taking ethinyl estradiol/norethindrone (Lo-Estrin), leuprolide, and medroxyprogesterone were significantly more likely to have apoplectic leiomyomas compared to women taking other hormonal therapies. Apoplectic leiomyomas were observed in 22.1% (77/349) of women ≤ 45 years of age compared to 11.3% (59/520) of women > 45 years of age (p < 0.0001), and this difference remained statistically significant regardless of hormone use.This is the largest study to date examining apoplectic leiomyomas in women on known hormonal therapy compared to women with uterine leiomyomas, but not on hormonal therapy. Information about hormonal therapy, ethnicity, and age can be helpful in the diagnostic interpretation of apoplectic leiomyoma."

Clinical • Journal • Hematological Disorders • Leiomyosarcoma • Oncology • Sarcoma • Solid Tumor • Uterine Corpus Leiomyosarcoma • Uterine Leiomyoma

A Study to Characterize the Pharmacokinetics of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Bristol-Myers Squibb; Not yet recruiting ➔ Recruiting

Enrollment open