Last update 29 Nov 2024
Norelgestromin
Last update 29 Nov 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms 17-Deacetylnorgestimate, 17-Deacylnorgestimate, 18-Methylnorethindrone oxime + [9] |
Target |
Mechanism PR agonists(Progesterone receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization- |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date- |
Regulation- |
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Structure
Molecular FormulaC21H29NO2 |
InChIKeyISHXLNHNDMZNMC-XUDSTZEESA-N |
CAS Registry53016-31-2 |
Related
5
Clinical Trials associated with NorelgestrominA Phase 3, Multicenter, Open-Label, Single-Arm Study of MR-130A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety
An Open-label, Phase II, Dose-finding Study of Three Dose Strengths of MR-130A-01 Contraceptive Transdermal Patch in Healthy Pre-menopausal Women
An open-label, phase II, dose-finding study of three dose strengths of MR-130A-01 contraceptive transdermal patch containing norelgestromin (NGMN) in healthy pre-menopausal women
100 Clinical Results associated with Norelgestromin
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100 Translational Medicine associated with Norelgestromin
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100 Patents (Medical) associated with Norelgestromin
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126
Literatures (Medical) associated with Norelgestromin01 Sep 2024REPRODUCTIVE BIOMEDICINE ONLINE
Effect of various contraceptives on oocyte yield and maturation in patients undergoing planned oocyte cryopreservation
Article
Author: Mukherjee, Tanmoy ; Siddiqui, Saher ; Copperman, Alan B ; Lee, Joseph ; Hernandez-Nieto, Carlos ; Mejia-Fernandez, Loreli ; Slifkin, Richard ; Alkon-Meadows, Tamar
RESEARCH QUESTION:
Do the various forms of hormonal and non-hormonal contraceptives have any association with ovarian stimulation outcomes, such as oocyte yield and maturation, in patients undergoing planned oocyte cryopreservation (POC)?
DESIGN:
This retrospective cohort study included all patients who underwent POC cycles between 2011 and 2023. The use of types of contraception before a POC cycle was recorded. The study evaluated the median number of cumulus-oocyte complexes obtained after vaginal oocyte retrieval and the proportion of metaphase II oocytes that underwent vitrification among all the cohorts.
RESULTS:
A total of 4059 oocyte freezing cycles were included in the analysis. Eight types of contraceptive method were recognized in patients undergoing ovarian stimulation: intrauterine device (IUD), copper (n = 84); IUD, levonorgestrel low dose (<52 mg) (n = 37); IUD, levonorgestrel (n = 192); subdermal etonogestrel implant (n = 14); injectable medroxyprogesterone acetate (n = 11); etonogestrel vaginal ring (n = 142); combined oral contraceptive pills (n = 2349); and norelgestromin transdermal patch (n = 10). The control group included patients not using contraceptives or using barrier or calendar methods (n = 1220). Among all the cohorts the median number of cumulus-oocyte complexes retrieved during oocyte retrieval was comparable (P = 0.054), and a significant difference in oocyte maturity rate with median number of vitrified oocytes was found (P = 0.03, P < 0.001, respectively). After adjusting for confounders a multivariate analysis found no association between the type of contraceptive and proportion of metaphase II oocytes available for cryopreservation.
CONCLUSIONS:
Among the various forms of contraception, none was shown to have an adverse association with oocyte yield or maturation rate in patients undergoing POC.
01 Sep 2024Contraception
Use of serum evaluation of contraceptive and ovarian hormones to assess reduced risk of pregnancy among women presenting for emergency contraception in a multicenter clinical trial
Article
Author: Teal, Stephanie ; Blithe, Diana L ; Brown, Jill ; Thomas, Michael ; Archer, David F ; Jensen, Jeffrey T ; Edelman, Alison ; Schreiber, Coutney A ; Westhoff, Carolyn L
OBJECTIVES:
To evaluate ovulation risk among women enrolling in an emergency contraception (EC) study by measuring contraceptive steroids and ovarian hormones.
STUDY DESIGN:
We used standard chemiluminescent assays to evaluate endogenous hormones (estradiol, progesterone, follicle stimulating hormone, luteinizing hormone) and liquid chromatography-tandem triple quadrupole mass spectrometry to simultaneously analyze concentrations of ethinylestradiol, dienogest, norelgestromin (NGMN), norethindrone (NET), gestodene, levonorgestrel (LNG), etonogestrel (ENG), segesterone acetate, medroxyprogesterone acetate (MPA), and drospirenone in serum samples obtained at the time of enrollment in a recent study comparing oral ulipristal acetate and LNG EC in women with weight ≥80 kg reporting no recent use of hormonal contraception.
RESULTS:
We enrolled 532 and obtained a valid baseline blood sample from 520 women. Of these, 117 (22.5%) had detectable concentrations of progestin (MPA [n = 58, 11.2%], LNG [50, 9.6%], ENG [11, 2.1%], NET [5, 0.96%], NGMN [3, 0.06%], or drospirenone [1, 0.02%]). LNG was co-detected in all three participants with samples containing NGMN. Multiple progestins were detected in eight other women: ENG/MPA (1), ENG/LNG (2), and MPA/LNG (5). Samples from 55 (10.6%) had concentrations of one or more progestin considered above the minimum level for contraceptive (MPA ≥ 0.1 ng/mL, n = 19; NGMN/LNG ≥ 0.2 ng/mL, n = 31; ENG ≥ 0.09 ng/mL, n = 8; NET ≥ 0.35 ng/mL, n = 4). We detected concentrations of serum progesterone ≥ 3 ng/mL, indicative of luteal phase (postovulation) status, in an additional 194 (37.3%) samples.
CONCLUSIONS:
More than one-third of enrolled in our clinical trial of oral EC had evidence of prior ovulation at the time of enrollment. Additionally, about 23% had evidence of recent use of hormonal contraception. These results would have decreased the expected risk of pregnancy in the study.
IMPLICATIONS:
Many participants in a recent clinical trial of oral emergency contraception did not appear to be at risk for pregnancy or would not have benefited from intervention due to cycle timing. Investigators should consider the effects of these findings on expected pregnancy rates when determining sample size in future EC clinical trials, particularly when using noninferiority designs or historical controls.
01 Oct 2023Contraception
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: Boniface, Emily R ; Erikson, David W ; Blue, Steven ; Waites, Bethany T ; Jensen, Jeffrey T ; McCrimmon, Sara
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.
2
News (Medical) associated with Norelgestromin11 May 2023
Phase 3AcquisitionDrug Approval
26 Feb 2021
Generic DrugBiosimilarAcquisition
100 Deals associated with Norelgestromin
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D05205 | Norelgestromin |
R&D Status
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Contraception | - | - | - |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 4 | 24 | Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets (Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill) | ekzskzuniw(kbybdudqje) = lefzihlerq abptzbvexv (tasxqejqay, xymthlrjsg - bfpepktggg) View more | - | 31 Mar 2010 | ||
ethinylestradiol patch oral contraceptive patch+norelgestrominum (Norelgestrominum and Ethinylestradiol Contraceptive Patch) | ekzskzuniw(kbybdudqje) = kdubkowxkl abptzbvexv (tasxqejqay, ohgaamknxm - orhdcknias) View more |
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