BACKGROUNDThe US Food and Drug Administration-approved segesterone acetate and ethinyl estradiol ring-shaped contraceptive vaginal system, known as Annovera (Sever Pharma Solutions/QPharma, Malmö, Sweden), was inserted and removed under a woman's control for a 21 day in and 7 day out regimen for up to 13 cycles of use.OBJECTIVEWe aimed to describe the patterns of ring expulsion over time, to identify potential predictors of expulsion, and to evaluate the impact of expulsions on method discontinuation and pregnancy risk.STUDY DESIGNUsing data from 2064 participants who were enrolled in 2 multinational phase 3 clinical trials on the use of this contraceptive vaginal system, we examined data from participants' daily diaries for documentation of complete ring expulsion. We modeled the odds of reported expulsions over time with adjustment for background and demographic characteristics using mixed-effects logistic regression models with random intercepts. We compared the probability of continuation between those who did and those who did not report expulsions in the first cycle of use using survival analysis and hazards modeling. To determine if expulsions during the first cycle of use affected the risk for pregnancy, we calculated Pearl Indices.RESULTSMost participants (75%) never experienced any expulsions during any cycle of use, and 91% to 97% did not experience an expulsion during any 1 cycle. The incidence of expulsion was highest in cycle 1 (9%). The odds of experiencing expulsions decreased by half in cycles 2 to 8 when compared with cycle 1 (0.48; 95% confidence interval, 0.40-0.58), and in cycles 9 to 13, expulsions were about a third of that in cycle 1 (0.32; 95% confidence interval, 0.26-0.41). Of those who did experience expulsions, most (62%-84%) experienced ≤2 expulsions per cycle. Participants from study sites in Latin America vs those in the United States had higher odds of not experiencing an expulsion (odds ratio, 1.95; 95% confidence interval, 1.45-2.63). Women with a higher education level had higher odds of experiencing an expulsion. Notably, parity, age, and body mass index were not associated with expulsion. Participants who experienced any expulsions in cycle 1 were more likely to discontinue use early (hazard ratio, 1.28; 95% confidence interval, 1.14-1.43) than participants who did not have an expulsion. The Pearl Index for participants who had expulsions during cycle 1 was 3.99 (95% confidence interval, 1.29-9.31), which was higher than that among participants who reported no expulsions (Pearl Index, 2.39; 95% confidence interval, 1.61-3.41), but the overlapping confidence intervals indicate that there is not sufficient evidence to demonstrate an association between expulsions and pregnancy risk.CONCLUSIONExpulsions were infrequent overall, decreased with subsequent cycles of use, and were not associated with body mass index or parity. Early discontinuation of product use was higher among participants who experienced an expulsion during cycle 1. Although it is unclear whether pregnancy risk was associated with expulsions, early recognition of expulsions among users may identify those at higher risk for discontinuation and may highlight when enhanced anticipatory counselling and guidance may be advantageous.

01 Apr 2024·Frontiers in Neuroendocrinology

Nestorone (segesterone acetate) effects on neuroregeneration

Review

Author: Brinton, Roberta ; Schumacher, Michael ; Guennoun, Rachida ; De Nicola, Alejandro F ; El-Etr, Martine ; Singer, Patrick ; Sitruk-Ware, Regine ; Sussman, Heather ; Kumar, Narender ; V Borlongan, Cesar

Nestorone® (segesterone acetate) is a progestin with a chemical structure closely related to progesterone with high affinity and selectivity for the progesterone receptor without significant interaction with other steroid receptors. It has been developed for female and male contraception and is FDA-approved in a first long-acting contraceptive vaginal system for female contraception. Its safety has been extensively demonstrated in both preclinical and clinical studies for contraceptive indications. Nestorone was found to display neuroprotective and neuroregenerative activity in animal models of various central nervous system diseases, including multiple sclerosis, stroke, and amyotrophic lateral sclerosis. Reviewed herein are neuroprotective and myelin- regenerating properties of Nestorone in various animal models and its translational potential as a therapeutic agent for debilitating neurological diseases for which limited therapeutic options are available (Table 1).

01 Oct 2023·Contraception

Development and validation of an expanded panel of progestins using liquid chromatography-tandem triple quadrupole mass spectrometry to monitor protocol compliance in hormonal contraceptive pharmacokinetic/pharmacodynamic studies

Article

Author: Waites, Bethany T ; Jensen, Jeffrey T ; Boniface, Emily R ; McCrimmon, Sara ; Erikson, David W ; Blue, Steven

We developed and validated the use of ultra-high-performance liquid chromatography-heated electrospray ionization-tandem triple quadrupole mass spectrometry to simultaneously analyze serum concentrations of ethinylestradiol, dienogest, norelgestromin, norethindrone, gestodene, levonorgestrel, etonogestrel, segesterone acetate, medroxyprogesterone acetate, and drospirenone. The calibration range for all targets was 0.009-10 ng/mL, with lower limit of quantification of 0.009 ng/mL for all analytes except gestodene (0.019 ng/mL). We used our assay to check compliance among participants in a clinical trial, confirmed the use of drospirenone in 11 of 13 study participants, and evidence of noncompliant progestins in 2 (levonorgestrel = 1, norethindrone = 1). We conclude that this approach provides an accurate method to check protocol compliance in contraceptive clinical trials. IMPLICATIONS: The availability of a liquid chromatography-tandem triple quadrupole mass spectrometry multiprogestin analysis panel for simultaneous evaluation of the most common contraceptive steroids approved worldwide could improve monitoring of compliance and protocol adherence in clinical trials.

News (Medical) associated with Segesterone acetate/Testosterone

12 Jun 2024

·www.drugs.com

ENDO: Novel Male Contraceptive Gel May Achieve Faster Sperm Suppression

WEDNESDAY, June 12, 2024 -- A novel male contraceptive gel suppresses sperm production faster than other hormone-based methods for male birth control, according to a phase 2 study presented at the annual meeting of the Endocrine Society, held from June 1 to 4 in Boston. Danielle Gross, from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health in Bethesda, Maryland, and colleagues assessed the time to sperm suppression (concentration ≤1 million/mL) with daily self-administration of segesterone acetate (8 mg)/testosterone (74 mg) combination gel in 222 healthy men. The researchers found that 86 percent of participants achieved suppression to ≤1 million/mL during treatment. One in five participants (21 percent) were suppressed to ≤1 million/mL at five weeks, which increased to 52 percent by eight weeks and 64 percent by nine weeks. The median time for those achieving suppression was eight weeks, with 82 percent suppressed within 12 weeks and 86 percent at 15 weeks of initiating treatment. "The development of a safe, highly effective and reliably reversible contraceptive method for men is an unmet need," senior author Diana Blithe, Ph.D., also of the National Institutes of Health, said in a statement. "While studies have shown that some hormonal agents may be effective for male contraception, the slow onset of spermatogenic suppression is a limitation." Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 2

20 May 2022

·www.biospace.com

TherapeuticsMD Receives U.S. Food and Drug Administration (FDA) Approval for Supplemental New Drug Application (sNDA) for ANNOVERA®

BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ:TXMD) (“TXMD” or the “Company”), an innovative, leading women’s healthcare company, today announced the FDA’s approval of a supplemental New Drug Application (sNDA) for ANNOVERA. The sNDA included minor revisions to ANNOVERA’s in vitro release testing specification that allowed for normal manufacturing variability. With the approval of the sNDA, the Company believes approximately 7,000 additional rings will be able to enter our supply chain and will be available to customers in the second and third quarters of 2022. Today's sNDA approval will enable TherapeuticsMD to better meet short- and long-term customer demand. “Today’s approval is an important milestone as it will allow us to more efficiently scale, manufacture, and consistently supply ANNOVERA to meet the increasing demand by women who want procedure-free, long-lasting reversible birth control,” said Hugh O’Dowd, Chief Executive Officer of TherapeuticsMD. ANNOVERA was approved by the FDA in August 2018 as the only long-lasting, reversible, procedure-free birth control. Please see the Full Prescribing Information, including indication and Boxed WARNING, for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Drug Review

100 Deals associated with Segesterone acetate/Testosterone

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception	Phase 2	-	The Population Council, Inc.	-

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