Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants
CONCLUSIONS: The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.PMID:37140071 | DOI:10.1111/head.14512 (Source: Headache)
Source: Headache - May 4, 2023 Category: Neurology Authors: Rajinder Bhardwaj Joseph C Stringfellow Beth Morris Robert S Croop Richard J Bertz Source Type: research
Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants
CONCLUSIONS: The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.PMID:37140071 | DOI:10.1111/head.14512 (Source: Headache)
Source: Headache - May 4, 2023 Category: Neurology Authors: Rajinder Bhardwaj Joseph C Stringfellow Beth Morris Robert S Croop Richard J Bertz Source Type: research
Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants
CONCLUSIONS: The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.PMID:37140071 | DOI:10.1111/head.14512 (Source: Headache)
Source: Headache - May 4, 2023 Category: Neurology Authors: Rajinder Bhardwaj Joseph C Stringfellow Beth Morris Robert S Croop Richard J Bertz Source Type: research
Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants
CONCLUSIONS: The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.PMID:37140071 | DOI:10.1111/head.14512 (Source: Headache)
Source: Headache - May 4, 2023 Category: Neurology Authors: Rajinder Bhardwaj Joseph C Stringfellow Beth Morris Robert S Croop Richard J Bertz Source Type: research
Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants
CONCLUSIONS: The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.PMID:37140071 | DOI:10.1111/head.14512 (Source: Headache)
Source: Headache - May 4, 2023 Category: Neurology Authors: Rajinder Bhardwaj Joseph C Stringfellow Beth Morris Robert S Croop Richard J Bertz Source Type: research
Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants
CONCLUSIONS: The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.PMID:37140071 | DOI:10.1111/head.14512 (Source: Headache)
Source: Headache - May 4, 2023 Category: Neurology Authors: Rajinder Bhardwaj Joseph C Stringfellow Beth Morris Robert S Croop Richard J Bertz Source Type: research
Effects of rimegepant 75 mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants
CONCLUSIONS: The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.PMID:37140071 | DOI:10.1111/head.14512 (Source: Headache)
Source: Headache - May 4, 2023 Category: Neurology Authors: Rajinder Bhardwaj Joseph C Stringfellow Beth Morris Robert S Croop Richard J Bertz Source Type: research
Development of a Translational Exposure-Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products
Clin Pharmacol Ther. 2022 Jun 20. doi: 10.1002/cpt.2690. Online ahead of print.ABSTRACTWorldwide, 922 million women of reproductive age (or their partners) use some sort of contraception to prevent pregnancy. Oral combined hormonal contraceptives (CHC) typically utilize a combination of a progestin and an estrogen. CHC are potentially at risk to metabolic drug-drug interaction (DDI) via CYP3A4, the main enzyme involved in the oxidative metabolism of ethinyl estradiol (EE) and most progestins, e.g. levonorgestrel (LNG) and drospirenone (DRSP). Recently, the FDA issued a guidance addressing metabolic DDIs in the realm of CHC...
Source: Clinical Pharmacology and Therapeutics - June 20, 2022 Category: Drugs & Pharmacology Authors: Brian Cicali Lais Da Silva Amir Sarayani Karthik Lingineni Michelle Pressly Soyoung Kim Thomas Wendl Joachim Hoechel Valvanera Vozmediano Almut G Winterstein Joshua D Brown Stephan Schmidt Rodrigo Cristofoletti Source Type: research
Development of a Translational Exposure-Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products
Clin Pharmacol Ther. 2022 Jun 20. doi: 10.1002/cpt.2690. Online ahead of print.ABSTRACTWorldwide, 922 million women of reproductive age (or their partners) use some sort of contraception to prevent pregnancy. Oral combined hormonal contraceptives (CHC) typically utilize a combination of a progestin and an estrogen. CHC are potentially at risk to metabolic drug-drug interaction (DDI) via CYP3A4, the main enzyme involved in the oxidative metabolism of ethinyl estradiol (EE) and most progestins, e.g. levonorgestrel (LNG) and drospirenone (DRSP). Recently, the FDA issued a guidance addressing metabolic DDIs in the realm of CHC...
Source: Clinical Pharmacology and Therapeutics - June 20, 2022 Category: Drugs & Pharmacology Authors: Brian Cicali Lais Da Silva Amir Sarayani Karthik Lingineni Michelle Pressly Soyoung Kim Thomas Wendl Joachim Hoechel Valvanera Vozmediano Almut G Winterstein Joshua D Brown Stephan Schmidt Rodrigo Cristofoletti Source Type: research
The paradigm of norgestimate: a third-generation testosterone-derivative progestin with a peripheral anti-androgenic activity and the lowest risk of venous thromboembolism.
Abstract
INTRODUCTION: Norgestimate (NGM) represents an interesting progestin, as it is a testosterone derivative with peculiar receptor activities.
AREAS COVERED: This is a narrative review of the available data on the pharmacotherapy of NGM in combined hormonal contraceptives (CHCs) in terms of contraceptive efficacy, venous thromboembolism (VTE) risk, safety, tolerability and bleeding patterns. A comprehensive literature review was conducted in August 2020 using PubMed with the keyword "norgestimate".
EXPERT OPINION: NGM shows a mild estrogenic activity associated with anti-mineralocorti...
Source: Pharmacological Reviews - January 19, 2021 Category: Drugs & Pharmacology Authors: Grandi G, Del Savio MC, Facchinetti F Tags: Expert Rev Clin Pharmacol Source Type: research
Risk of sexual dysfunction with progestin-based contraceptives in women of child-bearing age
ConclusionOur study found an increase in the use of levonorgestrel (COC and IUD), drospirenone, and medroxyprogesterone in subjects with SD. The risk of contraceptives did not differ when compared with oral levonorgestrel. The small association size and lack of difference between drug formulations suggest a minimal impact of progestin-based contraceptives on sexual dysfunction. (Source: European Journal of Clinical Pharmacology)
Source: European Journal of Clinical Pharmacology - January 1, 2021 Category: Drugs & Pharmacology Source Type: research
A high resolution LC–MS targeted method for the concomitant analysis of 11 contraceptive progestins and 4 steroids
Publication date: 25 October 2019Source: Journal of Pharmaceutical and Biomedical Analysis, Volume 175Author(s): Csaba Ferenc Laszlo, Jonathan Paz Montoya, Marie Shamseddin, Fabio De Martino, Alexandre Beguin, Rene Nellen, Stephen James Bruce, Marc Moniatte, Hugues Henry, Cathrin BriskenAbstractIn the context of hormonal contraception and hormone replacement therapy (HRT), many women are exposed to exogenous hormones. Current use of hormonal contraception with combined ethinyl estradiol and different progestins bestows a breast cancer relative risk (RR) of 1.2- while combined HRT has a RR of 2. Although these exposures pre...
Source: Journal of Pharmaceutical and Biomedical Analysis - August 5, 2019 Category: Drugs & Pharmacology Source Type: research
A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females
ConclusionErenumab did not alter the pharmacokinetics of the active components of an estrogen/progestin combination oral contraceptive. Thus, no change in contraceptive efficacy is expected with erenumab.Trial RegistrationClinicalTrials.gov NCT02792517. (Source: CNS Drugs)
Source: CNS Drugs - April 7, 2019 Category: Neurology Source Type: research
Evaluation of Potential Drug –Drug Interaction Between Delayed‐Release Dimethyl Fumarate and a Commonly Used Oral Contraceptive (Norgestimate/Ethinyl Estradiol) in Healthy Women
Abstract
Delayed‐release dimethyl fumarate (DMF) is an oral therapy for relapsing multiple sclerosis with anti‐inflammatory and neuroprotective properties. This 2‐period crossover study was conducted to evaluate the potential for drug–drug interaction between DMF (240 mg twice daily) and a combined oral contraceptive (OC; norgestimate 250 μg, ethinyl estradiol 35 μg). Forty‐six healthy women were enrolled; 32 completed the study. After the lead‐in period (OC alone), 41 eligible participants were randomized 1:1 to sequence 1 (OC and DMF coadministration in period 1; OC alone in period 2) or sequence 2 (regimen...
Source: Clinical Pharmacology in Drug Development - July 1, 2017 Category: Drugs & Pharmacology Authors: Bing Zhu, Ivan Nestorov, Guolin Zhao, Venkata Meka, Mark Leahy, Jeanelle Kam, Sarah I. Sheikh Tags: Original Manuscript Source Type: research
Combined Oral Contraceptive Pill Initiation in a Patient With Major Depressive Disorder, Premenstrual Dysphoric Disorder, Social Anxiety, Panic Disorder, and Histrionic Personality Disorder.
CONCLUSION: In this case, Beck Depression Inventory and Beck Anxiety Inventory scores, as well as self- and peer-reported functionality, all suggested improvement in symptoms following the introduction of COCPs. The neurohormonal contribution to psychiatric conditions continues to be studied and is becoming increasingly important. An understanding of the presence and etiology of premenstrual symptoms should be part of a comprehensive psychiatric assessment of female patients, and consideration of COCPs in the treatment plan adds a potentially potent option for symptom mitigation and remission.
PMID: 28638292 [PubMe...
Source: Ochsner Journal - June 24, 2017 Category: General Medicine Tags: Ochsner J Source Type: research
