Delving into the Latest Updates on 11βmethyl nortestosterone dodecylcarbonate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

11β-MNTDC, CDB-4754

Target

AR x PR

Action

modulators

Mechanism

AR modulators(Androgen Receptor modulators), PR modulators(Progesterone receptor modulators)

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

National Institute of Child Health & Human Development

Active Organization-

Inactive Organization-

License Organization-

Drug Highest Phase-

First Approval Date-

Regulation-

Structure/Sequence

Molecular FormulaC32H52O4

InChIKeyJVTCGMMASZPYDR-UIRZMXPTSA-N

CAS Registry904901-01-5

We asked participants from 3 clinical trials of investigational HMC methods-an oral pill (11β-Methyl-19-nortestosterone-17β-dodecylcarbonate, 11β-MNTDC), intramuscular or subcutaneous injection (Dimethandrolone undecanoate), and transdermal gel (Nestorone and testosterone)-to rank their top 3 preferred HMC providers from a list including: men's health doctor (urologist/andrologist), hormonal doctor (endocrinologist), reproductive health doctor (OB/GYN), family planning clinician (community health worker, midwife, nurse practitioner), regular doctor (family medicine/internal medicine), and community pharmacist. We examined preferences based on their rankings and conducted bivariate analyses. Collapsing the various specialists (men's health doctor, hormonal doctor, reproductive health doctor, and family planning clinician) into a single provider type, we examined participant demographics against provider preference (regular doctor, pharmacist, or specialist).

RESULTS:

Participants across the 3 trials (n = 124) ranked their regular doctor (44%) and community pharmacist (18%) as their most preferred HMC provider; these preferences did not differ significantly by trial and drug formulation. Specialists in family planning (13%), men's health (12%), reproductive health (10%), and hormones (4%) were least frequently ranked as their preferred provider. Older and higher educated participants more often preferred specialists over regular doctors and pharmacists (p = 0.02 and p = 0.01).

CONCLUSIONS:

Despite receiving contraceptive steroid hormones and care from endocrinologists and family planning specialists in a clinical trial, participants would prefer to obtain contraception from their regular doctor.

IMPLICATIONS:

As most men expect to obtain hormonal male contraceptives from their regular doctor when commercially available, primary care physicians should become familiar with HMCs and be prepared to provide counseling and options accordingly.

01 Nov 2021·ContraceptionQ2 · MEDICINE

Acceptability of the oral hormonal male contraceptive prototype, 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MNTDC), in a 28-day placebo-controlled trial

Q2 · MEDICINE

Article

Author: Nguyen, Brian T ; Liu, Peter Y ; Anawalt, Bradley D ; Thirumalai, Arthi ; Blithe, Diana L ; Long, Jill E ; Farrant, Maritza ; Fernando, Frances ; Wang, Christina ; Amory, John K ; Swerdloff, Ronald S ; Page, Stephanie T ; Yuen, Fiona

OBJECTIVE:

To determine men's satisfaction with and the potential acceptability of 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MNTDC) when used for 28 days as an experimental, once-daily, oral hormonal male contraceptive (HMC).

STUDY DESIGN:

We surveyed participants from a double-blind, randomized, placebo-controlled, phase 1 clinical trial, examining their experience with and willingness to use daily oral 11β-MNTDC for male contraception.

RESULTS:

Of 42 trial participants, 40 (30 11β-MNTDC, 10 placebo) completed baseline and end-of-treatment surveys. Based on a 28-day experience, few cited any baseline concerns about safety and drug adherence. Following treatment, nearly three-quarters (72.5%) of participants reported satisfaction with the study drug and nearly all (92.5%) would recommend the method to others. More than half of participants would be willing to pay for the study drug (62.5%) and indicated that the method exceeded initial expectations (53.9%). Nearly 90% reported that taking the pill was easy to remember and did not interfere with their daily routines. Approximately one-third of participants reported bothersome side effects (37% 11β-MNTDC vs. 20% placebo, p = 0.45). Given the option, 42% of participants would prefer a daily HMC pill over injectable regimens or a daily topical gel.

CONCLUSION:

A majority of participants in this short-term trial of daily oral 11β-MNTDC reported satisfaction with the regimen, would recommend it to others, and would pay to use the drug as HMC despite some bothersome side effects.

IMPLICATIONS:

Oral 11β-MNTDC would be an acceptable and preferable method among men desiring reversible hormonal male contraception (HMC). These data support further trials of novel oral HMCs such as 11β-MNTDC.

01 Sep 2021·AndrologyQ2 · MEDICINE

Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11β‐MNTDC in healthy men

Q2 · MEDICINE

Article

Author: Bross, Rachelle ; Blithe, Diana L. ; Page, Stephanie T. ; Fernando, Frances A. ; Wang, Christina ; Pak, Youngju ; Hull, Laura ; Yuen, Fiona ; Thirumalai, Arthi ; Swerdloff, Ronald S. ; Long, Jill E. ; Liu, Peter Y.

Abstract:

Background:

Dimethandrolone (DMA) and 11β‐methyl‐19‐nortestosterone (11β‐MNT) are two novel compounds with both androgenic and progestational activity that are under investigation as potential male hormonal contraceptives. Their metabolic effects have never been compared in men.

Objective:

Assess for changes in insulin sensitivity and adiponectin and compare the metabolic effects of these two novel androgens.

Materials/Methods:

In two clinical trials of DMA undecanoate (DMAU) and 11β‐MNT dodecylcarbonate (11β‐MNTDC), oral prodrugs of DMA and 11β‐MNT, healthy men received drug, or placebo for 28 days. Insulin and adiponectin assays were performed on stored samples. Mixed model analyses were performed to compare the effects of the two drugs. Student's t test, or the non‐parametric Kruskal‐Wallis test as appropriate, was used to evaluate for an effect of active drug versus placebo.

Results:

Class effects were seen, with decrease in HDL‐C and SHBG, and increase in weight and hematocrit, with no statistically significant differences between the two compounds. No changes in fasting glucose, fasting insulin, or HOMA‐IR were seen with either compound. There was a slight decrease in adiponectin with DMAU that was not seen with 11β‐MNTDC. An increase in LDL‐C was seen with 11β‐MNTDC but not with DMAU.

Discussion:

There were no significant changes in insulin resistance after 28 days of oral administration of these novel androgens despite a mild increase in weight. There may be subtle differences in their metabolic impacts that should be explored in future studies.

Conclusion:

Changes in metabolic parameters should be carefully monitored when investigating androgenic compounds.

100 Deals associated with 11βmethyl nortestosterone dodecylcarbonate

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SAT-040 (ENDO2020)	Not Applicable	-	85	DMAU 400mg	ilmgnnrclz(dqitbyiuzs) = ewattmqgfx atwnwnrsll (srfljqytvw ) View more	Positive	08 May 2020
				11β-MNTDC 400mg	ilmgnnrclz(dqitbyiuzs) = qcfckgrldq atwnwnrsll (srfljqytvw ) View more
SUN-LB042 (ENDO2019)	Not Applicable	-	40	Placebo	ogwohtqmbo(mwumsmxxxj) = 5 with acne fwpcymmigf (fglpnpbmgn ) View more	-	30 Apr 2019
				11β-MNTDC 200 mg