modelG03EA03
Extends from Pharmacokinetic.Models.PK_1C.
Information
| name: | PrasteroneAndEstrogen | |
| ATC code: | G03EA03 | route: | vaginal |
| compartments: | 1 | |
| dosage: | 6.5 | mg |
| volume of distribution: | 20 | L |
| clearance: | 1200 | mL/h |
| other parameters in model implementation | ||
Prasterone (dehydroepiandrosterone, DHEA) and estrogen combination is a hormonal therapy used for the treatment of symptoms associated with menopause, such as vulvar and vaginal atrophy. This drug is not widely approved as a combination product; DHEA and estrogens are available separately for specific indications related to hormone replacement.
Pharmacokinetics
No published pharmacokinetic model or direct pharmacokinetic parameter data for the combination of prasterone and estrogen with ATC code G03EA03 was found in the literature as of 2024. The pharmacokinetics must be estimated from known monotherapy parameters of DHEA and estrogens, but there are no direct studies or population PK models specific to the combination product.
References
Smith, T, et al., & Thacker, HL (2020). Postmenopausal Hormone Therapy-Local and Systemic: A Pharmacologic Perspective. Journal of clinical pharmacology 60 Suppl 2 S74–S85. DOI:10.1002/jcph.1740 PUBMED:https://pubmed.ncbi.nlm.nih.gov/33274517
Martel, C, et al., & Moyneur, É (2016). Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. The Journal of steroid biochemistry and molecular biology 159 142–153. DOI:10.1016/j.jsbmb.2016.03.016 PUBMED:https://pubmed.ncbi.nlm.nih.gov/26972555
Parameters
| Type | Name | Default | Description |
|---|---|---|---|
| Modelica.Units.SI.Mass | weight (from PK_1C) | 75 | patient weight (kg) |
| Modelica.Units.SI.SpecificVolume | VdPerKg (from PK_1C) | 0.9 | Volume of distribution (L/kg) |
| Modelica.Units.SI.MassFraction | F (from PK_1C) | 0.8 | bioavailiability (0-1) |
| Pharmacolibrary.Types.Clearance | Cl (from PK_1C) | 20 | clearance |
| Modelica.Units.SI.Time | adminTime (from PK_1C) | 60 | first administration time (s) |
| Modelica.Units.SI.Time | adminDuration (from PK_1C) | 600 | administration duration (s) |
| Modelica.Units.SI.Time | adminPeriod (from PK_1C) | 8*60*60 | period of administration (default 8 hours)(s) |
| Pharmacolibrary.Types.Mass | adminMass (from PK_1C) | 1000 | administration mass (mg) |
| Integer | adminCount (from PK_1C) | 8 | number of dose administered (1) |
| Pharmacolibrary.Types.Volume | Vd (from PK_1C) | VdPerKg*weight | Volume of distribution (m3) |
| Pharmacolibrary.Types.MassConcentration | Cmin (from PK_1C) | 0.004 | minimal therapeutic range |
| Pharmacolibrary.Types.MassConcentration | Cmax (from PK_1C) | 0.008 | minimal therapeutic range |
| Pharmacolibrary.Types.MassConcentration | Ctox_peak (from PK_1C) | 0.012 | toxicity peak level |
| Pharmacolibrary.Types.MassConcentration | Ctox_trough (from PK_1C) | 0.006 | toxicity trough level |
Connectors
| Type | Name | Default | Description |
|---|---|---|---|
| Types.ConcentrationOutput | C_central (from PK_1C) | ||
| Interfaces.ConcentrationPort_b | centralCPort (from PK_1C) |
Components
| Type | Name | Default | Description |
|---|---|---|---|
| Pharmacokinetic.NoPerfusedTissueCompartment | central (from PK_1C) | ||
| Pharmacokinetic.ClearanceDrivenElimination | elim (from PK_1C) | ||
| Sources.PeriodicDose | periodicDose (from PK_1C) | ||
| Modelica.Units.SI.Time | t1_2 (from PK_1C) | elimination half-life |
Revisions
- 06/2025 Tomas Kulhanek, generated model from data extracted from PUBMED, DrugBank and LLM(GPT4.1)