estradiol/norethindrone oral / Generic mfg. - LARVOL DELTA

The effect of antiseizure medications on the exposure to combined oral contraceptives: A systematic review and network meta-analysis. (PubMed, Epileptic Disord) - "Current recommendations may underestimate ASM effects on exposure to COC components, especially those in newer COCs. Greater caution is recommended with low-dose topiramate. For individuals treated with weak COC inducers without additional contraceptive means, COCs containing levonorgestrel or norethindrone might be preferable given their lower vulnerability to induction."

Journal • Retrospective data • CNS Disorders • Epilepsy

A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants (clinicaltrials.gov) - P1 | N=93 | Not yet recruiting | Sponsor: Eisai Inc.

New P1 trial

A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Trial completion date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: Jun 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date

A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A framework for assessing the safety of degraded pharmaceuticals for long-duration space missions - Part 1: framework development. (PubMed, Crit Rev Toxicol) - "Risk is characterized relative to established health-based exposure limits (HBELs) or threshold of toxicological concern values (TTCs). A companion article describes case studies that apply this framework to four different classes of APIs under consideration for use during exploration spaceflight: azithromycin, diclofenac, gabapentin, and oral contraceptive (combination of ethinyl estradiol and norethindrone)."

Journal • Review • Oncology

Comparison of Dermatologic and Neuropsychological Adverse Events of Oral Contraceptives, 2016-2020 (AAD 2026) - "Odds ratios (ORs) were determined using binary logistic regression with ethinyl estradiol (EE)/norethindrone (NET) as the reference comparator...Anxiety was more frequently reported with EE/levonorgestrel(OR 1.7, p<0.001) and EE/desogestrel(OR 2.0, p<0.001)... OCP formulations demonstrate distinct side effect profiles, with certain progestins (e.g., drospirenone, norgestimate) linked to higher dermatologic and neuropsychological adverse events. NET-only formulations may confer a more favorable profile for anxiety. These findings underscore the importance of individualized prescribing to minimize exacerbation of comorbid conditions."

Adverse events • Acne Vulgaris • CNS Disorders • Depression • Migraine • Mood Disorders

A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

New P1 trial

Comparison of Dermatologic and Neuropsychological Side Effects of Oral Contraceptives, 2016-2020. (PubMed, Open Access J Contracept) - "Ethinyl estradiol/Norethindrone was used as the reference pill, as it is the oldest and the most prescribed combination oral contraceptive...Multiple progestins may impact rates of acne and anxiety, with fewer effects on depression and migraine headaches. This knowledge may allow for the personalization of medication selection based on the patients' other co-morbid conditions."

Adverse events • Journal • Acne Vulgaris • CNS Disorders • Depression • Migraine • Mood Disorders • Pain • Psychiatry

Ovulation Incidence in Oral Contraceptive Users (clinicaltrials.gov) - P3 | N=58 | Completed | Sponsor: University of Southern California | Suspended ➔ Completed

Trial completion

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